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

Catalog Number 1800250-33

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889)

Patient Problem Embolism/Embolus (4438)

Event Date 03/14/2024

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the ostial left anterior descending (lad) coronary artery without calcification or tortuosity.A 2.5x33 mm xience skypoint stent delivery system (sds) was being used for the procedure.The stent was released, the balloon was deflated and during withdrawal of the sds without resistance, the distal 30 cm of the device separated and embolized to the diagonal branch.A snare was attempted to retrieve the separated piece but was unsuccessful, so another guide and a balloon were advanced next to the separated piece and was able to remove the separated portion.The procedure lasted 2 hours, however, there was no impact to the patient.No additional information was provided.

Manufacturer Narrative

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

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 19034143
• MDR Text Key: 339267535
• Report Number: 2024168-2024-04186
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648230554
• UDI-Public: (01)08717648230554(17)260907(10)3091841
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1800250-33
• Device Lot Number: 3091841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2023
• 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