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

Catalog Number	1125300-28
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); Thrombosis (2100)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was no reported device malfunction and the product was not returned as it remains implanted.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 effects of angina, nausea, myocardial infarction and thrombosis are listed in the xience alpine, everolimus eluting coronary stent system, instructions for use (ifu) 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 manufacture, design or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a coronary stenting procedure with implantation of a 3.0 x 28 mm xience alpine stent in the proximal circumflex (cx) artery.On (b)(6) 2018, the patient experienced chest pain and was re-hospitalized.Medication was administered.Electrocardiogram noted changes with inferior myocardial infarction (mi).Coronary angiography was performed and noted thrombus in the implanted xience alpine stent.Revascularization, with thrombectomy, was performed at the target lesion and the patient condition resolved.On (b)(6) 2018, the patient experienced angina and vomiting and was re-hospitalized with acute mi.Troponin levels were elevated and indicated mi.Medication was administered as treatment of the angina and vomiting.Coronary angiography noted thrombus in the xience alpine stent in the cx artery.Revascularization, with thrombectomy, was performed as treatment of the angina, thrombus and mi.On (b)(6) 2018, the patient was re-hospitalized with complaints of angina and troponin levels were noted to be elevated.Medication was administered as treatment of the angina; however, no treatment was provided for the elevated troponin levels.The angina resolved on (b)(6) 2018 and the troponin levels trended down throughout the hospitalization.Antiplatelet medication was changed; clopidogrel was discontinued and ticagrelor was started.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: 7588827
• Report Number: 2024168-2018-04372
• Device Sequence Number: 2044489
• Product Code: NIQ
• UDI-Device Identifier: 08717648199370
• UDI-Public: 08717648199370
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: 02/07/2021
• Device Catalogue Number: 1125300-28
• Device Lot Number: 8013142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/11/2018
• 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; Disability
• Patient Age: 65 YR
• Patient Weight: 77