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

Catalog Number	1550250-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	04/05/2019
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 effects of angina and thrombosis are listed in the sierra, everolimus eluting coronary stent systems 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 manufacture, design or labeling.The 2.5x15 mm (8102442) xience sierra stent referenced is filed under a separate medwatch report.
Event or Problem Description
It was reported that the patient presented with chest pain of 7 days and dyspnea of 4 days.Coronary angiography was performed, and thrombus was noted in the left anterior descending (lad) artery.A myocardial infarction was diagnosed.Intervention was performed and two xience sierra stents (2.5x15 mm (8102442), 2.5x23mm (9011541) were implanted in overlapping fashion in the lad.The activated clotting time (act) was 260 on a first measurement and 400 on a second measurement.The patient was administered aspirin and plavix; however, it was noted that the patient was plavix-resistant.On (b)(6) 2019, the patient was re-hospitalized with chest pain of 1 day.The lad was noted to be occluded with thrombus in the stented segment.The patient was referred for surgical consult and underwent a coronary artery bypass graft (cabg) procedure on an unspecified date.Post-surgical procedure, the patient was reported to be doing well.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: 8562865
• Report Number: 2024168-2019-03402
• Device Sequence Number: 1537924
• Product Code: NIQ
• UDI-Device Identifier: 08717648227110
• UDI-Public: 0108717648227110
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/29/2019

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: 01/24/2020
• Device Catalogue Number: 1550250-23
• Device Lot Number: 9011541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/29/2019
• 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; Disability
• Patient Age: 60 YR