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

Catalog Number	1125400-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: guide catheter: 6 french jr4, embolic protection: spider.Evaluation summary: the device was returned for analysis.The reported material deformation (mangled stent) was confirmed.The reported device damaged by another (explanted) and difficult to remove could not be replicated in a testing environment as it was based on circumstances of the procedure.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.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 4.0x18 xience alpine was deployed proximal to a non-abbott stent in the mid right coronary artery (rca).A non-abbott filter was being removed through the xience alpine, but the filter was only partially enclosed in its retrieval catheter.The filter inadvertently removed the xience stent from the mid rca.When this was noted, the filter, stent, and guide catheter were removed from the anatomy as one unit, but the stent had become mangled and was left behind in the radial artery access site.The mangled stent was surgically removed through a one and a half inch cutdown at the radial artery.The patient remained hemodynamically stable.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: 7427426
• Report Number: 2024168-2018-02748
• Device Sequence Number: 19261891
• Product Code: NIQ
• UDI-Device Identifier: 08717648199622
• UDI-Public: 08717648199622
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: 04/09/2020
• Device Catalogue Number: 1125400-18
• Device Lot Number: 7033141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/12/2018
• 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: 47 YR
• Patient Weight: 114