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

Catalog Number	1125275-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2017
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.Evaluation summary: the device was returned for analysis.The reported deflation issue was able to be confirmed.The reported inflation issue was unable to be confirmed however there was noted device damage (kink) which likely contributed to the reported difficulties.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 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 the procedure was to treat chronic total occlusion of the proximal left anterior descending artery that was non-tortuous, non-calcified and 90% stenosed.After performing thrombus aspiration, the xience alpine 2.75 x 23 mm stent was deployed however the balloon did not inflate or deflate properly.The stent delivery system was inflated 3 times to 12 atmospheres for 30 seconds each time.Every time the balloon was inflated, the balloon did not inflate at all when pressure was applied at 2-3 atm.Then, the balloon suddenly inflated after a few seconds.This happened during each inflation.It is unknown how many seconds that negative was held to deflate the balloon however it was reported that it took longer than usual to deflate after each inflation however it was less than 30 seconds each time.The balloon was removed fully deflated and the procedure was completed without performing post-dilatation with blood flow improving to 90%.There was no leak or other issues noted during preparation and the device was prepped per the instructions for use.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: 6745474
• Report Number: 2024168-2017-06225
• Device Sequence Number: 210222
• Product Code: NIQ
• UDI-Device Identifier: 08717648199271
• UDI-Public: 08717648199271
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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: 02/11/2018
• Device Catalogue Number: 1125275-23
• Device Lot Number: 5020341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2017
• Initial Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1