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

Catalog Number	1125325-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Occlusion (1984)
Date of Event	08/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The xience alpine stents (3.00x23mm, 3.25x18mm) referenced are being filed under separate medwatch reports.The device was not returned for evaluation.The event was reviewed by an abbott vascular clinical specialist who concluded the death in this case is due to lack of anti-platelet anti-thrombotic medication and thrombosis occurred.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of death and occlusion are listed in the xience alpine everolimus eluting coronary stent system, instructions for use as known patient effects.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a st elevated myocardial infarction with confirmed multi vessel disease (proximal and mid left anterior descending (lad), circumflex and obtuse marginal coronary arteries).Following pre-dilatation with three unspecified balloons, dual anti-platelet medication was given.The activated clotting time (act) was noted to be out of normal range.A 3.00x23 mm xience alpine stent was deployed in the mid lad and a 3.25x23 mm xience alpine stent was deployed in the proximal lad.Haziness of unknown cause was noted at the ostium of the lad and circumflex.Following pre-dilatation of the circumflex with a 3.0x15 balloon, further dual antiplatelet therapy was given.A 3.25x18 mm xience alpine stent was deployed in the circumflex.Blood flow to the lad and circumflex was lost.Vasodilator medication was given.A 4.00x18 mm xience alpine stent was deployed in the left main; however, blood flow was not able to be re-established.The patient arrested.An aspiration catheter was unable to be advanced and cardiopulmonary resuscitation was attempted.The patient expired during 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: 7834621
• Report Number: 2024168-2018-06783
• Device Sequence Number: 13968621
• Product Code: NIQ
• UDI-Device Identifier: 08717648199455
• UDI-Public: 08717648199455
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2021
• Device Catalogue Number: 1125325-23
• Device Lot Number: 8011041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/30/2018
• 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: STENT: XIENCE ALPINE (3.00X23, 3.25X18, 4.00X18)
• Outcome Attributed to Adverse Event: Death