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

Catalog Number	1125300-38
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	01/21/2016
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, myocardial infarction and thrombosis are listed in the instructions for use as known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience alpine device referenced is being filed under separate medwatch reports.
Event or Problem Description
It was reported that on (b)(6) 2015 the patient underwent coronary intervention for treatment of a heavily calcified mid left anterior descending artery and the diagonal artery with a 3.0 x 38 mm xience alpine stent and a 2.5 x 23 mm xience alpine stent and was placed on dual antiplatelet therapy.In (b)(6) 2016, he was taken off his medications by his stomach doctor as he was experiencing a stomach bleed.The patient was not able to see his cardiologist prior to this occurring.On (b)(6) 2016 the patient experienced an acute myocardial infarction and was rehospitalized and underwent revascularization of the stents as his stents had clotted off due to being taken of his medications.He was informed at the time of the reintervention that one of his stents had possibly moved or was damaged but he does not know which one but assumed it was the diagonal.The thrombus was treated with balloon angioplasty successfully.The patient is asking if having a possible fractured stent or having a stent that may have moved would make it difficult for him to have an mri of his hip.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: 6316210
• Report Number: 2024168-2017-01095
• Device Sequence Number: 11033138
• Product Code: NIQ
• UDI-Device Identifier: 08717648199394
• UDI-Public: (01)08717648199394(17)171110(10)4110441
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2017

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: 11/10/2017
• Device Catalogue Number: 1125300-38
• Device Lot Number: 4110441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/09/2017
• 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: 2.5 X 23 MM XIENCE ALPINE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 70