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

Catalog Number	1125250-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
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.(b)(4).The device was not returned for analysis.In the xience alpine instructions for use the first step under the preparation section includes steps for removing the device from the foil and inner pouches and removing the product mandrel and protective sheath.The next section includes steps related to flushing the guide wire lumen and preparing the device by removing air from the system.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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a concentric de novo lesion (diameter 2.5 mm x length 33 mm) located from mid to distal left anterior descending (lad) artery with mild tortuosity and mild calcification that was 75% stenosed.A 2.5 x 38 mm xience alpine rx stent delivery system (sds) was advanced to the lesion and crossed; however during stent deployment, air was observed to be pulled into the indeflator.It was reported that the leak originated from the hub and the hub was confirmed to be cracked.Air aspiration (device prep) was performed outside the anatomy and again inside the anatomy prior to stent deployment.The physician stated that the device might have been over tightened.There were no adverse patient effects or clinically significant delay in the procedure 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: 6401449
• Report Number: 2024168-2017-02088
• Device Sequence Number: 780129
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: (01)08717648199219(17)191207(10)6112841
• 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): 03/13/2017

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: 12/07/2019
• Device Catalogue Number: 1125250-38
• Device Lot Number: 6112841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1