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

Model Number 1074275-33

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

Patient Problems Cardiac Arrest (1762); Embolism (1829); Myocardial Infarction (1969); Thrombosis (2100); Ventricular Fibrillation (2130); Prolapse (2475)

Event Date 02/20/2020

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, 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 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.

Manufacturer Narrative

See b5 for additional information.Na.

Event 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
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9861612
• MDR Text Key: 187411392
• Report Number: 2024168-2020-02731
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162275
• UDI-Public: 08717648162275
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 96