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

Catalog Number	1125300-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2016
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.Concomitant medical products: guide wire: sion blue, guide cath: mach1 7f vl3.5, other: filtrap.Evaluation summary: a visual, dimensional and functional inspection was performed on the returned device.The reported shaft kink was able to be confirmed.The reported difficulty to position guide wire was unable to be replicated in a testing environment due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that due to a build-up of thrombus on the filter guide wire after thrombus aspiration was performed the 3.0 x 28 mm xience alpine met resistance with the guide wire resulting in the reported difficulty to position.Manipulation of the device resulted in the reported shaft kink and the noted multiple device damages.
Event or Problem Description
It was reported that the procedure was to treat an eccentric de novo lesion located in the mid left anterior descending coronary artery that was mildly tortuous, non-calcified and 90% stenosed.Due to a build-up of thrombus on the filter guide wire after thrombus aspiration was performed, the 3.0 x 28 mm xience alpine met resistance with the guide wire and was unable to advance any further so the device was removed from the anatomy.The mid-shaft was confirmed to be kinked.The device was replaced with a same size xience alpine to successfully complete the procedure.There were no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed an innermember separation.

• 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: 6203449
• Report Number: 2024168-2016-09276
• Device Sequence Number: 716778
• Product Code: NIQ
• UDI-Device Identifier: 08717648199370
• UDI-Public: (01)08717648199370(17)181104(10)5102161
• 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,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2016

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: 11/04/2018
• Device Catalogue Number: 1125300-28
• Device Lot Number: 5102161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 12/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 68