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

Catalog Number	1125275-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The whisper ms guidewire referenced is filed under a separate medwatch report number.Evaluation summary: the device was returned for analysis.The stent dislodgement was 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 failure to advance and stent dislodgement to be related to interactions with the deployed stent.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 heavily calcified tibial artery.A 014 whisper ms guidewire was selected for the procedure.While crossing the lesion the tip of the 014 whisper ms guidewire broke off.The physician decided to embed the guidewire tip into the vessel wall with a stent implant.An unspecified stent implant was used but the stent only covered 70% of the guidewire tip as it had migrated a little.The physician decided to use a second stent implant to cover the remaining part of the guidewire tip.A 2.75 x 28 mm xience alpine stent delivery system (sds) was selected.The sds was advanced over a new unspecified guidewire and while traversing through the previously implanted stent, the stent implant dislodged from the sds onto the guidewire.The sds was removed from the anatomy and the stent implant remained on the guidewire.The physician was able to massage over the skin, and massaged the stent out of the access site.The procedure was aborted at that point and the patient was stable.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: 6559308
• Report Number: 2024168-2017-04055
• Device Sequence Number: 16176347
• Product Code: NIQ
• UDI-Device Identifier: 08717648199288
• UDI-Public: (01)08717648199288(17)191025(10)6101841
• 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): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: 1125275-28
• Device Lot Number: 6101841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/10/2017
• 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: GUIDEWIRE: .014 WHISPER MS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR