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

Catalog Number	1125275-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The kink and inflation issue were confirmed.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.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 lesion in the mildly tortuous, heavily calcified, 90% stenosed distal right coronary artery (rca).A 2.75 x 15 mm xience alpine stent delivery system (sds) was advanced to the lesion and would not cross.Using the double guide wire technique the sds was able to cross the lesion.An attempt was made to inflate the balloon and the pressure on the indeflator gauge did not rise.The sds was removed from the anatomy and the shaft of the sds was found to be kinked proximal to the guide wire exit notch.The sds was replaced with a new 2.75 x18 mm xience alpine sds.Using a single guide wire, new sds was advanced to the lesion and would not cross.Using the double guide wire technique the new sds was able to cross the lesion and the stent implant was successfully deployed.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.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: 6312675
• Report Number: 2024168-2017-01048
• Device Sequence Number: 16346430
• Product Code: NIQ
• UDI-Device Identifier: 08717648199257
• UDI-Public: (01)08717648199257(17)190801(10)6071841
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: 08/01/2019
• Device Catalogue Number: 1125275-15
• Device Lot Number: 6071841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: SION BLUE