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

Catalog Number	1125350-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
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 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 and treatment appear to be related to circumstances of the procedure as it is likely the entangled guide wired interacted with the previously deployed stent causing the reported device damaged by another device and subsequent removal of a foreign body with additional therapy/non-surgical treatment.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 performed to treat a lesion in the mid circumflex with no tortuosity or calcification.The 3.5 x 23 mm xience alpine stent delivery system (sds) was advanced to the lesion without issue, and deployed successfully.The sds was removed without issue and standard post-dilatation was performed.The un-specified procedure guide wire was left in place and a second non-abbott guide wire was advanced for treatment of the obtuse marginal; however, the guide wires became entangled.An unknown balloon was advanced in an attempt to untangle the guide wires, but the balloon could not be fully advanced.The guide wires were gradually retracted, and it was observed that the second guide wire had caught on the alpine stent and dislodged it from its deployed location.The guide wire was removed and the stent was free floating in the aorta.A second access site was used to advance a snare device, and the stent was successfully retrieved from the anatomy.A new non-abbott stent was used to re-treat the lesion and the patient had a good outcome.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: 7431297
• Report Number: 2024168-2018-02794
• Device Sequence Number: 13860503
• Product Code: NIQ
• UDI-Device Identifier: 08717648199547
• UDI-Public: 08717648199547
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/13/2018

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: 06/13/2020
• Device Catalogue Number: 1125350-23
• Device Lot Number: 7060741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/13/2018
• 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