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

Catalog Number	1125350-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2016
Type of Reportable Event	Serious Injury
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 and complaint history could not be conducted because the lot number was not provided.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 malposition; however, the treatment appears to be related to circumstances of the procedure.
Event or Problem Description
It was reported that the procedure was to treat restenosis of the left anterior descending artery.Predilatation was performed prior to the deployment of the 3.5 x 28 mm xience alpine stent.There was no resistance reported during advancement of the stent delivery system to the lesion.During deployment it was observed that the proximal end of the stent implant was not fully opening but was able to be deployed; however, the proximal end of the stent implant was still observed to be not fully open.A 1.5 x 5 mm balloon was advanced inside the stent implant and inflated to fully appose the proximal end of the stent to the vessel wall.This was followed by normal post-dilatation of the stent.No adverse patient effects or clinically significant delay of the procedure were reported.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: 5903770
• Report Number: 2024168-2016-05682
• Device Sequence Number: 10926855
• Product Code: NIQ
• UDI-Device Identifier: 08717648199554
• UDI-Public: (01)08717648199554
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1125350-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2016
• Initial Report FDA Received Date: 08/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention