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

Catalog Number	1125225-28
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/16/2017
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.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mid circumflex artery.It was noticed that the stent was loose on the delivery system of a 2.25x28mm xience alpine stent delivery system after removal from the packaging.The procedure was successfully completed with another unknown device.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Correction: it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.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 other similar incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation was unable to determine a conclusive cause for the reported unstable stent.

• 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: 6400747
• Report Number: 2024168-2017-02064
• Device Sequence Number: 13464601
• Product Code: NIQ
• UDI-Device Identifier: 08717648199103
• UDI-Public: (01)08717648199103(17)191025(10)6101741
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 04/13/2017

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: 10/25/2019
• Device Catalogue Number: 1125225-28
• Device Lot Number: 6101741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1