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

Catalog Number	1125275-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The xience alpine everolimus eluting coronary stent system instructions for use, states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients.In addition, the xience alpine stent system is indicated for treating de novo chronic total coronary occlusions.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during a procedure of the right anterior tibial artery using a contralateral approach in a heavily tortuous groin, the 2.75 x 12 mm xience alpine stent was advanced with anatomical resistance and successfully deployed at the target lesion without issue.During removal of the stent delivery system (sds) without resistance the shaft became separated near the tuohy and was easily removed from the anatomy while on the guide wire.There was no reported adverse patient effect.Another stent was implanted to complete the procedure.There was no reported adverse patient effect.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: 5844173
• Report Number: 2024168-2016-05140
• Device Sequence Number: 269492
• Product Code: NIQ
• UDI-Device Identifier: 08717648199240
• UDI-Public: (01)08717648199240(17)180608(10)5060241
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2016

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: 06/08/2018
• Device Catalogue Number: 1125275-12
• Device Lot Number: 5060241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2016
• Initial Report FDA Received Date: 08/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1