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

Catalog Number 1012165-38

Device Problems Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that procedure was to treat a 90% stenosed de novo lesion in the left circumflex artery with heavy calcification and mild tortuosity.Pre-dilation was performed and then the 2.50x38mm multi-link stent delivery system (sds) was attempted to advanced to the target lesion; however, failed to advanced due to the anatomy.The shaft of the sds was observed to be kinked and a stent strut was flared.During removal of the sds the shaft separated in two pieces outside of the patient anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.The sds was replaced with another same size multi-link was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported deformation due to compressive stress, material deformation and material separation were confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 15230130
• MDR Text Key: 300458498
• Report Number: 2024168-2022-08773
• Device Sequence Number: 1
• Product Code: MAF
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012165-38
• Device Lot Number: 1062341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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