MAUDE Adverse Event Report: ABBOTT VASCULAR RX SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550300-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	10/10/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 death and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system, electronic 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 of the device.The additional xience sierra stents referenced are filed under separate medwatch report numbers.
Event or Problem Description
Patient id: (b)(6).It was reported that the procedure on (b)(6) 2020 was to treat 90% stenosed de novo lesions in the distal and mid right coronary artery (rca).Two xience sierra stents (3.0x38 mm and 3.50x38 mm) were successfully implanted overlapping.Pre and post-dilatation were performed.Stent apposition was confirmed with intravascular ultrasound (ivus) with 0% stenosis.The patient was discharged on (b)(6) 2020; however, it was reported that the patient expired on (b)(6) 2020 due to an unknown cause.In this study, death of an unknown cause within 30 days after stent deployment is defined as probable stent thrombosis.Clopidogrel and rivaroxaban had been administered to prevent stent thrombosis.No additional information was provided.

• Brand Name: RX SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10814109
• Report Number: 2024168-2020-09354
• Device Sequence Number: 2113947
• Product Code: NIQ
• UDI-Device Identifier: 08717648227301
• UDI-Public: 08717648227301
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: 02/17/2023
• Device Model Number: 1550300-38
• Device Catalogue Number: 1550300-38
• Device Lot Number: 0021141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.50X38, 2.50X28. 3.0X23 MM XIENCE SIERRA STENTS
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR
• Patient Weight: 76