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

Catalog Number	1125350-18
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Thrombosis (2100)
Date of Event	10/24/2017
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 device was not returned and the stent remains in the patient anatomy.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 thrombosis are listed in the xience alpine, everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.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.The 3.5 x 12mm xience alpine is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the patient presented with an acute myocardial infarction.The patient was administered aspirin 300 mg while being transferred to the hospital by ambulance and effient was administered just prior to the procedure.The procedure was to treat a non-tortuous, non-calcified distal left anterior descending (lad) coronary artery with a thrombotic occlusion that was 99% stenosed.Thrombosis was confirmed by angiography and was aspirated.Pre-dilatation was performed and a 3.5 x 18mm xience alpine stent was deployed in the distal lad.Some of the thrombosis migrated to the peripheral part of the vessel and there was some thrombosis remaining proximal to the deployed 3.5 x 18 xience alpine stent.Thus, a 3.5 x 12mm xience alpine stent was deployed proximal to the other stent.The stents were confirmed to be well apposed to the vessel wall.Thrombosis started to form again and the vessel was occluded.Thrombosis also formed in the left circumflex (cx).Therefore, thrombus aspiration was performed repetitively, but the occlusion continued.Algatroban was administered but the patients condition deteriorated and the patient died due to cardiac arrest as a result of the thrombotic occlusion of the lad and cx.It was noted that the thrombosis formation was likely inflicted by heparin-induced thrombocytopenia (hit) and that there was no correlation between the cause of the thrombosis formation and the xience alpine stents.The patient had also stopped taking their prescribed medication for diabetes/hypertension, which is assumed to have largely caused the thrombus formation.An autopsy was not performed.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: 6999750
• Report Number: 2024168-2017-08642
• Device Sequence Number: 13692086
• Product Code: NIQ
• UDI-Device Identifier: 08717648199530
• UDI-Public: 08717648199530
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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 Expiration Date: 07/25/2020
• Device Catalogue Number: 1125350-18
• Device Lot Number: 7071441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/03/2017
• 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: 3.5 X 12MM XIENCE ALPINE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR