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

Catalog Number	1125225-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2018
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 not returned for analysis.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter and/or the guiding catheter extender during advancement causing the reported stent dislodgement.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 target lesion in the diagonal artery.A 6french guide catheter and a 6french guide catheter extension were used.The 2.25 x 12 mm xience alpine stent delivery system was advanced through the guide catheter extension; however, upon exiting the guide catheter extension, the stent was not on the stent delivery system balloon.It was assumed that the stent remained in the guide catheter extension.The guide catheter, guide catheter extension and stent delivery system were removed as a single unit and the stent was found in the guide catheter extension.New devices were prepared and a 2.25 x 12 mm xience alpine stent was deployed at the target lesion without issue.There were no adverse patient effects and no clinically significant delay.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: 7236018
• Report Number: 2024168-2018-00764
• Device Sequence Number: 1017934
• Product Code: NIQ
• UDI-Device Identifier: 08717648199066
• UDI-Public: 08717648199066
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/01/2018

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: 11/06/2020
• Device Catalogue Number: 1125225-12
• Device Lot Number: 7102561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR