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

Catalog Number 1500275-33

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

Patient Problems Angina (1710); Cardiac Arrest (1762); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 03/27/2024

Event Type  Death  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a moderately calcified, moderately tortuous proximal left anterior descending (lad) artery that was stenosed.The lesion was pre-dilated with an unspecified device and a 2.75x33mm xience sierra stent was deployed.Post dilatation was performed with a 3.0x20mm non-abbott balloon.The procedure was completed without issue and patient was shifted to critical care unit (ccu).The next morning (b)(6) 2024, the patient experience severe chest pain, went into cardiac arrest and subsequently cardiopulmonary resuscitation (cpr) was initiated.Angiography revealed thrombosis in the lad stent.Thrombosuction was performed; however, thrombus migrated to the left circumflex and occluded the artery.The patient eventually passed away.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: 19127773
• MDR Text Key: 340424067
• Report Number: 2024168-2024-04792
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648218422
• UDI-Public: (01)08717648218422(17)270108(10)4011141
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1500275-33
• Device Lot Number: 4011141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Death