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

Catalog Number	1125400-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was able to be confirmed.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 incidents from this lot.The investigation determined a conclusive cause for the reported stent dislodgement cannot be determined and 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 xience alpine stent delivery system (sds) was positioned at the proximal left anterior descending artery (lad) lesion when the stent implant was noted to be missing.The patient anatomy was checked using fluoroscopy and the stent was not located in the anatomy.The sds and the non-abbott guide catheter were removed from the anatomy.A different non-abbott guide catheter was used and a different stent was deployed in the vessel without issue.There was no reported adverse patient sequela or a clinically significant delay in the procedure.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: 6774605
• Report Number: 2024168-2017-06498
• Device Sequence Number: 531562
• Product Code: NIQ
• UDI-Device Identifier: 08717648199608
• UDI-Public: 08717648199608
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/08/2017

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: 03/08/2020
• Device Catalogue Number: 1125400-12
• Device Lot Number: 7030141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR