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

Catalog Number	1125400-15
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	01/05/2018
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 revealed no manufacturing nonconformities that would have contributed to this event.The reported patient effects of angina and thrombosis are listed in the xience alpine, everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a 75% stenosed, mildly tortuous and mildly calcified de novo lesion in the mid right coronary artery.On (b)(6) 2017, the patient presented with a sub-acute myocardial infarction.A 4.0x15mm xience alpine stent was implanted and the patient was discharged on (b)(6) 2017.On (b)(6) 2018, the patient was re-hospitalized with chest pain.An angiogram and optical coherence tomography (oct) confirmed thrombosis.The thrombosis was treated with a thrombus-aspiration catheter, balloon dilatation, and a 3.5x22mm non-abbott stent was implanted.The physician suspected that the stent thrombosis occurred due to the patient not taking dual antiplatelet drug therapy after stenting.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: 7229645
• Report Number: 2024168-2018-00703
• Device Sequence Number: 11196719
• Product Code: NIQ
• UDI-Device Identifier: 08717648199615
• UDI-Public: 08717648199615
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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: 05/22/2020
• Device Catalogue Number: 1125400-15
• Device Lot Number: 7051641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 01/30/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 57