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

Catalog Number	1125400-15
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/13/2016
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.Visual and dimensional inspections were performed on the returned device.The stent dislodgement was confirmed.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.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 the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that during preparation of a 4.0 x 15 mm xience alpine stent delivery system, when removing the protective sheath and stylet, the stent dislodged.There was no resistance removing the protective sheath.The device was not used.Another xience alpine was successfully used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).

• 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: 6226961
• Report Number: 2024168-2017-00118
• Device Sequence Number: 11027167
• Product Code: NIQ
• UDI-Device Identifier: 08717648199615
• UDI-Public: (01)08717648199615(17)190704(10)6062941
• 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,Followup
• Report Date (Section B): 01/10/2017

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: 07/04/2019
• Device Catalogue Number: 1125400-15
• Device Lot Number: 6062941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1