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

Catalog Number	1550350-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	04/04/2019
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 xience sierra everolimus eluting coronary stent systems instructions for use, as a 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 3.0x38mm xience sierra stent referenced is filed under a separate medwatch report.
Event or Problem Description
It was reported that the patient was hospitalized on (b)(6) 2019, after 3 days of experiencing chest discomfort, diagnosed with st elevation myocardial infarction (mi).Two xience sierra stents (3.0 x 38 mm, 3.5 x 15 mm) were implanted in the left anterior descending (lad) artery, in an overlapping fashion.The activated clotting time (act) was noted to be 331 on the first measurement, and 303 on the second.Post procedure, the patient experienced residual chest pain, diagnosed as dressler's syndrome, as a result of the mi.One day post procedure, the patient had complaints of continued chest pain.An integrilin bolus was administered and coronary angiography was performed, noting thrombus in the lad, stented segment, which was 100% occluded.An edge dissection was noted at the distal edge of the lad stented segment.A 3.0 x 18 mm xience sierra stent was implanted to treat the dissection.Post procedure, the patient was in stable condition.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: 8575906
• Report Number: 2024168-2019-03499
• Device Sequence Number: 2387364
• Product Code: NIQ
• UDI-Device Identifier: 08717648227417
• UDI-Public: 08717648227417
• 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): 05/02/2019

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: 12/13/2019
• Device Catalogue Number: 1550350-15
• Device Lot Number: 8120741
• 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: 05/02/2019
• 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: Required Intervention
• Patient Age: 43 YR