GRAFTMASTER 1012581-26

[183274790] (b)(4). The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no similar incidents from this lot. The graftmaster was used past the expiration date. A review of the graftmaster label attached to the lot history record for this lot was conducted indicating a manufacturing date of (b)(6) 2018 with an expiration date (use by date) of (b)(6) 2019. The product was used after expiration as it was reported the procedure occurred on (b)(6) 2020. The expiration date of the product is important for sterility, efficacy, and performance of the device. It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, states: note the product use by date specified on the package. The investigation determined the reported device expiration issue appears to be related to the use error. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10

[183274791] It was reported that a 3. 5x26mm graftmaster covered stent was used to treat a free perforation that occurred in the mid left anterior descending coronary artery on (b)(6) 2020. The stent successfully covered the perforation; however, the stent was used after the expiration date of (b)(6) 2019. As per the physician, the graftmaster did not cause or contribute to additional complications or adverse events. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5