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

Catalog Number 1012649-38

Device Problems Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2024

Event Type  malfunction  

Event Description

It was reported the procedure was to treat a moderately calcified and tortuous lesion in the leg.Air aspiration was not performed on the 3.50x38mm rx xience prime stent delivery system (sds) prior to use.The sds was advanced to the lesion however upon inflation it was not possible to deploy the stent.Liquid was noting coming out of a hole in the shaft.The sds was removed without issue and the procedure completed with another xience stent.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

H6: medical device problem code 2017 clarifier- incorrect prep manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• Brand Name: XIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL 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: 19171881
• MDR Text Key: 340912581
• Report Number: 2024168-2024-05032
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648178986
• UDI-Public: (01)08717648178986(17)251112(10)3111641
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012649-38
• Device Lot Number: 3111641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• 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