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

Catalog Number	1125350-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2018
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.The device was returned for analysis.The hypotube was separated proximal to the guide wire exit notch.The proximal portion, including the hub were not returned.The reported material deformation (bent and flared stent) was confirmed.The reported failure to advance the device was unable to 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.Review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The account was contacted in regards to the shaft separation; however, they were unaware of any shaft separation.It is possible the shaft separation took place after the procedure.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 performed to treat a heavily calcified and heavily tortuous lesion in the left circumflex coronary artery.The vessel was predilated and the 3.5x12 mm xience alpine stent was inserted, but met a lot of resistance with the calcified anatomy.It was unable to advance further and the stent delivery system (sds) was retracted from the anatomy.There was no resistance removing the sds from the anatomy.After the sds was removed, longitudinal stent damage was noted; the stent was also flared and prolapsed.A non-abbott stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.This is being filed for the proximal shaft separation found during device investigation on the returned device.Follow-up with the customer indicated the customer was not aware of the shaft separation.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: 7580760
• Report Number: 2024168-2018-04296
• Device Sequence Number: 2364871
• Product Code: NIQ
• UDI-Device Identifier: 08717648199516
• UDI-Public: 08717648199516
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: 01/17/2019
• Device Catalogue Number: 1125350-12
• Device Lot Number: 6011241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1