MAUDE Adverse Event Report: ABBOTT VASCULAR MULTI-LINK 8; CORONARY STENT DELIVERY SYSTEM

Catalog Number 1012168-23

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

H6: medical device problem code: 2017 clarifier: failure to follow steps: instructions.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.

Event Description

It was reported the procedure was to treat a lesion in the mid left anterior descending artery.The 3.50x23mm multilink 8 stent delivery system was prepared for use prior to removing the protective sheath.The sds was advanced to the lesion and the balloon inflated however it was noted the stent was not on the balloon.The stent was located inside the protective sheath on the preparation table.The procedure was completed using another multilink 8 of the same size.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: MULTI-LINK 8
• Type of Device: 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: 19004117
• MDR Text Key: 338945387
• Report Number: 2024168-2024-03893
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648130502
• UDI-Public: (01)08717648130502(17)250331(10)2042841
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P020047
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012168-23
• Device Lot Number: 2042841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2022
• 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