MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1125250-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported stent dislodgement and the reported material deformation were able to be confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 other similar incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified proximal left anterior descending artery.A 2.5 x 12 mm xience alpine stent delivery system (sds) was advanced to the lesion without resistance and inflated.The device was removed from the anatomy without issue.Angiography was performed and there was no stent visible in the anatomy.A 2.5 x 23 mm xience alpine sds was being advanced through the co-pilot and when reaching the connection between the guiding catheter and the co-pilot there was strong resistance and the xience alpine sds could not be advanced.The stent delivery system was removed and the co-pilot and guiding catheter were pulled back slightly to reveal the 2.5 x 12 mm xience alpine stent that had dislodged when attempting to advance earlier in the procedure.The stent was in a ball.The stent was removed and a non-abbott stent was successfully implanted to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6577111
• Report Number: 2024168-2017-04292
• Device Sequence Number: 1134271
• Product Code: NIQ
• UDI-Device Identifier: 08717648199158
• UDI-Public: (01)08717648199158(17)200205(10)7011961
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2020
• Device Catalogue Number: 1125250-12
• Device Lot Number: 7011961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR