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

Catalog Number 1011709-23

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

Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Thrombosis (2100)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The reported patient effect(s) of angina and thrombosis is listed in the xience prime everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.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 to treat a 90% stenosed, mildly tortuous, and mildly calcified de novo lesion in the left anterior descending artery.Following pre-dilatation with an unspecified 2.0x12mm non-compliant (nc) balloon catheter at 12 atmospheres (atms) and 14 atms, a 3.0x23mm xience prime stent was deployed at 10 atms.Post-dilation was performed with an unspecified 3.0x15mm nc balloon catheter at 16 atms.Following post-dilation, the patient was shifted to the cardiac intensive care unit and after some time the patient developed chest pain and st changes were observed.The patient was sent to the lab where an angiogram revealed distal thrombosis which was treated with a 3.0x15mm xience v stent.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE PRIME 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: 11263095
• MDR Text Key: 229808461
• Report Number: 2024168-2021-00774
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2023
• Device Catalogue Number: 1011709-23
• Device Lot Number: 0021041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention