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

Catalog Number	1125300-28
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombosis (2100); Heart Failure (2206)
Date of Event	03/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The reported patient effects of myocardial infarction and thrombosis are listed in the xience alpine, everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.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 on (b)(6) 2018 was to treat a mildly tortuous, proximal left anterior descending artery (lad) that was 100% stenosed.The patient presented with a myocardial infarction (mi).After aspirating thrombosis, a 3.0 x 28 mm xience alpine stent was successfully deployed and post-dilated.Intravascular ultrasound (ivus) confirmed the stent was fully opposed the vessel wall.The patient was prescribed dual antiplatelet therapy (dapt) of aspirin and prasugrel and discharged from the hospital on (b)(6) 2018.On (b)(6) 2018 the patient returned to the hospital with acute mi and cardiac failure due to in-stent thrombosis.The patient had discontinued their dapt.The cardiac failure was treated with drug therapy.Angiography was performed to confirm thrombosis.Thrombus aspiration and balloon angioplasty were performed with a good timi 3 blood flow.As of (b)(6) 2018 the patient remains hospitalized undergoing cardiac rehabilitation.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: 7474280
• Report Number: 2024168-2018-03170
• Device Sequence Number: 1124312
• Product Code: NIQ
• UDI-Device Identifier: 08717648199370
• UDI-Public: 08717648199370
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: 10/04/2020
• Device Catalogue Number: 1125300-28
• Device Lot Number: 7091961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/30/2018
• 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