MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for GRAFTMASTER 1012818-26 manufactured by Abbott Vascular.
[184053883]
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The additional graftmaster device referenced is being filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[184053884]
It was reported that the patient presented with st-elevation myocardial infarction (stemi). Angiography showed an occlusion of the right coronary artery (rca) and during percutaneous coronary intervention (pci), a perforation was noted with bleeding to the pericardial sac. The 3. 5x26 mm graftmaster covered stent was attempted to be placed with a balance middleweight (bmw) guide wire as well as a 6fr non-abbott guide catheter; however, the stent could not exit the distal part of the guide catheter and the proximal shaft was broken close to the hemostatic valve. The graftmaster was removed and the 2. 80x19 mm graftmaster covered stent was attempted but again it could not exit the guide catheter and the proximal shaft was broken. A non-abbott stent was used to treat the perforation without any issue and the bleeding was stopped. Reportedly, 2-3 days after the procedure the patient died from cardiogenic shock. Per the physician, the patient arrived with cardiogenic shock. The delay with the graftmasters during the procedure did not contribute to the patient death. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02155 |
| MDR Report Key | 9806190 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2018-07-26 |
| Date Added to Maude | 2020-03-09 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTMASTER |
| Generic Name | CORONARY STENT DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 2020-03-09 |
| Catalog Number | 1012818-26 |
| Lot Number | 8072641 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |