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

Catalog Number	1125400-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
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: only the stent implant was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported difficult to remove from the anatomy and the reported difficult to remove from the guiding catheter were unable to be replicated in a testing environment as they were 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 identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the device was being removed interaction with the calcified vessel resulted in the reported difficult to remove.Interaction as the stent reached the ostium of the guiding catheter resulted in the reported difficult to remove from the guiding catheter.As all devices were being removed as one unit interaction with the vessel resulted in the noted stent damages (mangled, stretched) and ultimately resulted in the reported stent dislodgment.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was a transcatheter aortic valve implantation (tavi).The physician had concerns regarding protection of the left main artery; therefore, a 4.0 x 15 mm xience alpine stent delivery system (sds) was advanced without resistance into the left main artery to manage coronary obstruction during tavi.However, the physician decided that the stent was too short and decided to remove the sds.Reportedly, there was no issue with labeling, the physician just chose the wrong size.During removal of the sds, resistance was met with the calcified vessel and when the stent reached the ostium of the guiding catheter, the stent became stuck.Therefore, all devices were removed as one unit, but the stent got hung up with the vessel and dislodged in the radial artery.A snare device was used to recover the dislodged stent successfully.A non-abbott sds was used successfully in the procedure.There was no adverse patient sequela.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: 7172852
• Report Number: 2024168-2018-00160
• Device Sequence Number: 917406
• Product Code: NIQ
• UDI-Device Identifier: 08717648199615
• UDI-Public: 08717648199615
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/08/2018

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: 04/25/2020
• Device Catalogue Number: 1125400-15
• Device Lot Number: 7041841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR