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

Catalog Number 1011707-38

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

Patient Problems Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 04/01/2020

Event Type  Death  

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 ventricular tachycardia, ventricular fibrillation, cardiac arrest, and death are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent systems instructions for use as 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

It was reported that the procedure was performed on (b)(6) 2020 to treat a de novo lesion in the moderately calcified, moderately tortuous, 99% stenosed left anterior descending (lad) coronary artery and a de novo lesion in a heavily calcified, mildly tortuous, 90% stenosed right coronary artery (rca).The patient presented with hypertension and a myocardial infarction.A 3x12 mm trek balloon was used for pre-dilatation.Two xience prime stents (2.5x38 mm and 3x38 mm) were successfully implanted in the lad, and a 2.75x12 xience v stent was successfully implanted in the rca.After the procedure, the patient experienced ventricular tachycardia, ventricular fibrillation, and cardiac arrest, so cardiopulmonary resuscitation (cpr) was given as treatment.The patient subsequently died on (b)(6) 2020.In the physicians opinion, the xience stents did not cause or contribute to the death.No additional information was provided.

• Brand Name: XIENCE PRIME
• 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: 10095927
• MDR Text Key: 192388656
• Report Number: 2024168-2020-04563
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Catalogue Number: 1011707-38
• Device Lot Number: 9061041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death