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

Catalog Number	1125250-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.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 effect(s) of angina and thrombosis are listed in the xience alpine, everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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 other two xience alpine stents are filed under separate manufacturing report numbers.
Event or Problem Description
It was reported that on (b)(6) 2018, two 2.5x12mm xience alpine stents were implanted, one in the 2nd obtuse marginal and one in the 3rd obtuse marginal coronary arteries.A 2.5x23mm xience alpine stent was also implanted in the 1st diagonal coronary artery.Reportedly, stent placement angiographic appearances were acceptable.Post procedure and prior to hospital discharge, the patient reported abdominal cramping and tridil infusion was provided.Chest pain grade 9/10 was reported and aggrastat infusion was initiated.Another angiogram was performed.Stent thrombosis was noted in the proximal left anterior descending artery, 1st diagonal, mid circumflex, and ostial 2nd obtuse marginal.Another percutaneous intervention was performed as treatment with additional stent placement.The event resolved without sequela.There was no device malfunction.No additional information was provided regarding this issue.

• 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: 7794830
• Report Number: 2024168-2018-06352
• Device Sequence Number: 11146886
• Product Code: NIQ
• UDI-Device Identifier: 08717648199189
• UDI-Public: 08717648199189
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 01/23/2021
• Device Catalogue Number: 1125250-23
• Device Lot Number: 8011541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/17/2018
• 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
• Patient Age: 61 YR
• Patient Weight: 85