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

Model Number	1550250-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Respiratory Failure (2484)
Date of Event	01/07/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id (b)(6).It was reported that on (b)(6) 2019, the procedure was performed to treat a lesion in the 1st obtuse marginal artery.A 2.5 x 12 mm xience sierra stent was implanted without complication.On (b)(6) 2020, the patient presented to the emergency room with complaints of shortness of breath, hypoxemia and hypotension.Acute respiratory acidosis was diagnosed and the patient was placed on bilevel positive airway pressure (bipap).Intravenous (iv) dopamine was administered.Cardiac enzyme elevation and electrocardiogram changes were noted.Stent thrombosis was suspected; however, no additional testing was performed and the patient and family requested to be do not resuscitate (dnr) status and was admitted to hospice.The patient was discharged to hospice on (b)(6) 2020.On (b)(6) 2020, the patient passed away with acute on chronic respiratory failure.No autopsy was performed.Per study physician, the congestive heart failure, precipitating acute on chronic respiratory failure and cardio-pulmonary shock was caused by the possible stent thrombosis.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.The reported patient effect(s) of death, thrombosis, and hypotension 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 review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.H1: type of reportable event.

• 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: 9645243
• Report Number: 2024168-2020-01020
• Device Sequence Number: 2482890
• Product Code: NIQ
• UDI-Device Identifier: 08717648227080
• UDI-Public: 08717648227080
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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: 09/23/2020
• Device Model Number: 1550250-12
• Device Catalogue Number: 1550250-12
• Device Lot Number: 9091841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/14/2020
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 84