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

Catalog Number	1125350-28
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual inspection was performed on the returned device.The reported missing components (stent) was confirmed.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 missing components (stent) appears to be related to circumstances of the procedure.Based on the information reviewed and analysis of the returned device, 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 located in the left anterior descending coronary artery.When the xience alpine 3.5 x 28 mm stent delivery system was removed from its protective tubing and the mandrel and protective sheath were removed, there was no stent found on the balloon.The device was not used and there was no patient involvement.Another xience alpine was used to complete the procedure.The protective coil, stylet, and floor were all inspected; however, no stent was found.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.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: 7468443
• Report Number: 2024168-2018-03125
• Device Sequence Number: 18858526
• Product Code: NIQ
• UDI-Device Identifier: 08717648199554
• UDI-Public: 08717648199554
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/27/2018

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: 11/06/2019
• Device Catalogue Number: 1125350-28
• Device Lot Number: 6102841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1