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

Catalog Number	1550300-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Nausea (1970); Thrombosis (2100)
Date of Event	03/03/2019
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.The reported patient effect(s) of angina, nausea, and thrombosis are listed in the xience sierra, everolimus eluting coronary stent systems instructions for use 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.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient presented with multiple vessel coronary artery disease and a 3.00 x 33 mm xience sierra stent was implanted in the right coronary artery with no tortuosity and no calcification.On (b)(6) 2019, the patient developed chest pain and nausea symptoms.Myocardial infarction was not diagnosed; however, ekg changes were noted and medication was given.On (b)(6) 2019 angiography was performed and stent thrombosis was identified.Moderate clot aspiration was achieved with a non-abbott thrombectomy device and balloon angioplasty was performed with a nc trek balloon dilatation catheter to restore flow.The patient was reported to be doing well post procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 8492181
• Report Number: 2024168-2019-02717
• Device Sequence Number: 1538261
• Product Code: NIQ
• UDI-Device Identifier: 08717648227295
• UDI-Public: 08717648227295
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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: 11/06/2019
• Device Catalogue Number: 1550300-33
• Device Lot Number: 8110141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/08/2019
• 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: 64 YR
• Patient Weight: 82