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	Prolapse (2475)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: guide wire: rinato, guide catheter: hyperion.The device was not returned for evaluation.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The tenku rx is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, mildly calcified, concentric, and de novo first diagonal artery that was 90% stenosed.An unspecified xience alpine stent was implanted in the proximal left anterior descending artery when plaque shift occurred at the entrance of the first diagonal.A 1.5 x 12 mm rx tenku was being used to dilate the vessel when the balloon ruptured on the first inflation after 10 seconds at 6 atmospheres.A non-abbott balloon was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.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: 6528647
• Report Number: 2024168-2017-03726
• Device Sequence Number: 18890027
• Product Code: NIQ
• UDI-Device Identifier: 08717648199271
• UDI-Public: (01)08717648199271(17)191115(10)6110741
• 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): 04/27/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2019
• Device Catalogue Number: 1125275-23
• Device Lot Number: 6110741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/27/2017
• 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: Other
• Patient Age: 78 YR
• Patient Weight: 69