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 Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	12/19/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, death is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.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 procedure was to treat a lesion in the ostium.A 4.0x15mm xience alpine stent was implanted; however, it looked undersized.It was decided to post-dilate the stent; however, the patient went into cardiac arrest before another device could be advanced.Chest compressions were applied, a percutaneous ventricular assist device was put in, and the patient was taken to the intensive care unit.Additional information was received stating that the patient died the same day as 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: 6248349
• Report Number: 2024168-2017-00416
• Device Sequence Number: 732994
• Product Code: NIQ
• UDI-Device Identifier: 08717648199615
• UDI-Public: (01)08717648199615
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1125400-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/12/2017
• 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: Death
• Patient Age: 78 YR
• Patient Weight: 82