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

Model Number	1074275-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Embolism (1829); Myocardial Infarction (1969); Thrombosis (2100); Ventricular Fibrillation (2130); Prolapse (2475)
Date of Event	02/20/2020
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, thrombosis, ventricular fibrillation and embolism are listed in the xience xpedition 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) 2020, the patient underwent a coronary procedure, performed to treat a lesion in the proximal left anterior descending coronary artery.The 2.75 x 33 mm xience xpedition stent was implanted.During the procedure, plaque shift occurred, requiring additional dilatation.On (b)(6) 2020, the patient was re-hospitalized with ventricular fibrillation arrest and anterior wall myocardial infarction.Resuscitation was performed.In-stent thrombosis was noted, with distal embolization.A revascularization procedure was performed and the patient condition continues.No additional information was provided.
Additional Manufacturer Narrative
See b5 for additional information.Na.
Event or Problem Description
Subsequent to the initial 30 day medwatch report, the following information was received: the stent thrombosis, with associated adverse effects of myocardial infarction and ventricular fibrillation, resolved on (b)(6) 2020; however, the patient was left with cognitive communication difficulties, as well as physical deconditioning.No additional information was provided.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9861612
• Report Number: 2024168-2020-02731
• Device Sequence Number: 2373319
• Product Code: NIQ
• UDI-Device Identifier: 08717648162275
• UDI-Public: 08717648162275
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/17/2020

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: 03/03/2022
• Device Model Number: 1074275-33
• Device Catalogue Number: 1074275-33
• Device Lot Number: 9022541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 07/17/2020
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 96