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

Catalog Number 1500225-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969)

Event Date 12/21/2020

Event Type  Injury  

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 and embolism is listed in the xience sierra everolimus eluting coronary stent systems instructions for use ifu) as known patient effects of coronary 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 Description

Patient id: (b)(6).It was reported that the procedure was performed to treat a target lesion in the mid left anterior descending (lad) artery.Three xience sierra stents were implanted: a 2.25 x 23 mm, a 3.0 x 28 mm, and a 3.5 x 23 mm.Post procedure, the patient experienced a cardiac enzyme elevation.The patient was diagnosed as having a myocardial infarction, which was suspected to be caused by distal embolization of plaque material during the procedure.The patient did not experience any chest pain, and there was no hemodynamic instability or electrocardiogram change.No intervention was performed and the event resolved on the day of discharge (b)(6) 2020.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11263830
• MDR Text Key: 229840237
• Report Number: 2024168-2021-00784
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2023
• Device Catalogue Number: 1500225-23
• Device Lot Number: 0013041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.0 X 28MM XIENCE SIERRA; 3.5 X 23MM XIENCE SIERRA
• Patient Outcome(s): Disability
• Patient Age: 74 YR
• Patient Weight: 72