MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-11-23 for SPIDER RX UNK-PLY-SPIDERRX manufactured by Covidien.
[128282643]
Date of event: date of article presentation to the forty-first annual symposium of the society for clinical vascular surgery, miami, fla, march 12-16, 2013. J vasc surg. 2014 february ; 59(2): 359? 367. E1. Doi:10. 1016/j. Jvs. 2013. 07. 119. Https://doi. Org/10. 1016/j. Jvs. 2013. 07. 119. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[128282644]
The study was carried out on 566 patients. Patients were treated for femoropopliteal endovascular interventions, treatment of the contralateral limb and reinterventions in a previously treated limb between 2002 and 2012 were used in the study. Indications for endovascular revascularization were claudication or critical limb ischemia. Endovascular interventions consisted of angioplasty, self-expanding stent grafts, primary or secondary stenting (ptas) and percutaneous atherectomy. The spider rx 3-7mm and 6mm was used with a 0. 35 catheter, terumo sheath, 0. 018 boston guidewire. Two patients had decreased flow caused by embolic protection. In one patient filter retrieval was difficult using the 0. 014 wire, which prompted routine use of the double wire technique. Failure of the spider rx included malposition, under sizing, dislodgement during retrieval. Patient? S presented with embolization, occlusion, formation of platelet or thrombus emboli beyond the filter device, amputation. Patients had moderate debris in the filter basket. In one patient, possible embolization occurred during retrieval of the spider. A second patient with a thrombus emboli, the cause of which was thought to have originated beyond the spider due to stagnant flow or inadequate systemic heparinization. The two patients who had small emboli did not require intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2018-00526 |
| MDR Report Key | 8099563 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-11-23 |
| Date of Report | 2019-02-07 |
| Date of Event | 2013-03-12 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2018-11-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 4600 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIDER RX |
| Generic Name | DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC |
| Product Code | NFA |
| Date Received | 2018-11-23 |
| Catalog Number | UNK-PLY-SPIDERRX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 4600 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-23 |