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	Angina (1710); Thrombosis (2100); Test Result (2695)
Date of Event	05/04/2018
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 evaluation.A review of the lot history record was not performed because the lot number was not reported and the product was not returned for analysis.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of angina 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.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 left anterior descending coronary artery.On (b)(6) 2018, the 3.25x23mm xience alpine was implanted.The patient was compliant with the antiplatelet drug.On (b)(6) 2018, the patient returned with chest pain, angiography was performed and in-stent thrombosis of the implanted xience alpine stent was confirmed.The patient was treated with an unspecified balloon dilatation catheter.On an unspecified date, the patient failed a stress test, thus on (b)(6) 2018, the patient was brought back for re-catheterization.The xience alpine was confirmed to have remained patent.The patient is stable.There was no adverse patient sequelae.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: 7655460
• Report Number: 2024168-2018-05119
• Device Sequence Number: 1512108
• Product Code: NIQ
• UDI-Device Identifier: 08717648199455
• UDI-Public: 08717648199455
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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 Catalogue Number: 1125325-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/02/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 71