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

Catalog Number	1125225-18
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/03/2016
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.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 reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the stent movement/mislocation.
Event or Problem Description
It was reported that a little resistance was felt during removal of the xience alpine 2.25 x 18 mm stent delivery system (sds) from the dispenser coil.Upon removal of the sds, the stent implant was found to not be crimped between the markers; the stent was located proximally.There was no reported resistance felt or force applied during the removal of the product mandrel/stent sheath and no manipulation/handling of the stent at any point.The device was not used for the procedure.There was no patient involvement.There was no reported 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: 5884384
• Report Number: 2024168-2016-05496
• Device Sequence Number: 620035
• Product Code: NIQ
• UDI-Device Identifier: 08717648199080
• UDI-Public: (01)08717648199080(17)181123(10)5111741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2016

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: 11/23/2018
• Device Catalogue Number: 1125225-18
• Device Lot Number: 5111741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2016
• Initial Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1