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

Model Number	1550325-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Thrombosis (2100); Dizziness (2194); Stenosis (2263); Prolapse (2475)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
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 myocardial infarction, stenosis, thrombosis and hypotension 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.
Event or Problem Description
Patient id (b)(6).It was reported that on (b)(6) 2019, the patient underwent a coronary stenting procedure to treat a lesion in the proximal right coronary artery (rca).A 3.25 x 28 mm xience sierra stent was implanted without issue.On (b)(6) 2020, the patient presented to the emergency room with lightheadedness and stated they had been feeling weak and lightheaded since the stenting procedure.Additionally, blood pressure was low and cardiac enzymes were elevated.Myocardial infarction was diagnosed.Medications were administered.Cardiology was consulted and angiography was performed, revealing severe in-stent restenosis and thrombosis.Intravenous ultrasound (ivus) noted prolapsed calcific plaque through the stent struts.Revascularization was performed on (b)(6) 2020, with angioplasty, stent implantation and aspiration thrombectomy.The event resolved on (b)(6) 2020.No additional information was provided.

• 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: 9624121
• Report Number: 2024168-2020-00869
• Device Sequence Number: 13998070
• Product Code: NIQ
• UDI-Device Identifier: 08717648227363
• UDI-Public: 08717648227363
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 01/23/2020

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: 04/26/2020
• Device Model Number: 1550325-28
• Device Catalogue Number: 1550325-28
• Device Lot Number: 9041941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/23/2020
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 73 YR
• Patient Weight: 81