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

Catalog Number	1550325-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 stenosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) 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 two additional xience sierra stents are filed under separate medwatch report numbers.Stents remain implanted in the patient.There was no device malfunction reported.
Event or Problem Description
It was reported that in (b)(6) 2018 the patient had a myocardial infarction that was treated with three xience sierra stents (two were sizes 3.25x23 and one 3.25x33) in the proximal and mid right coronary arteries and two non-abbott stents in the mid left circumflex coronary artery and in the diagonal artery (sizes 2.0x15 and 2.0x18).At the one year follow-up visit on (b)(6) 2019, the angiogram found several blockages in the coronary artery.A five vessel coronary artery bypass graft surgery was performed on (b)(6) 2019.Reportedly, the patient continued to have chest pain after the xience stents were implanted in 2018.The patient was removed from the ventilator on (b)(6) 2019.The patient was discharged home on (b)(6) 2019.

• Brand Name: XIENCE 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: 9272128
• Report Number: 2024168-2019-13139
• Device Sequence Number: 160801
• Product Code: NIQ
• UDI-Device Identifier: 08717648227356
• UDI-Public: 08717648227356
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2019

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: 06/24/2019
• Device Catalogue Number: 1550325-23
• Device Lot Number: 8061341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/04/2019
• 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: XIENCE SIERRA STENTS: 3.25X23, 3.25X33
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 77