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

Catalog Number	1125250-15
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	02/01/2017
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 analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The patient effects of angina, myocardial infarction and thrombosis are listed in the xience alpine everolimus eluting coronary stent system electronic instructions for use as potential adverse events of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the stent malposition and patient effects and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The other 2.5x15mm xience alpine stent referenced is filed under a separate medwatch report.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient was admitted with st elevation myocardial infarction (stemi) and underwent a coronary artery stenting procedure.Two 2.5 x 15 mm xience alpine stents were implanted and the patient was placed on dual antiplatelet therapy (dapt).On (b)(6) 2017, the patient was re-hospitalized with angina and stemi was diagnosed.Coronary angiography noted thrombosis in both stents.Additionally, it was noted that the stents were not well apposed to the vessel wall and not well expanded.Balloon angioplasty was performed using a 3.5 unspecified nc dilatation catheter, fully expanding the stents so that they were well apposed to the vessel wall.Post procedure, the patient was in stable condition.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: 6311780
• Report Number: 2024168-2017-01032
• Device Sequence Number: 974919
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: (01)08717648199165(17)191025(10)6101741
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: 1125250-15
• Device Lot Number: 6101741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 02/08/2017
• 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: 2.5X15 RX XIENCE ALPINEPLAVIX, ASPIRIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 98