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

Catalog Number 1012165-38

Device Problems Material Separation (1562); Stretched (1601); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 10/23/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous, 90% stenosed, de novo lesion in the distal left circumflex artery.The lesion was pre-dilatated and a 2.5x38mm multi-link 8 stent delivery system (sds) was advanced; however, resistance was felt with the anatomy, and the stent failed to cross, resulting in the shaft becoming kinked.During removal of the sds, the device separated into two pieces at a location outside of the anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.A new 2.5x38mm multi-link 8 sds was used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The material separation, deformation, stretched, and material split/cut were confirmed.The failure to advance could not be confirmed as this is related to the circumstances of the procedure and cannot be replicated in a lab environment.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 identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.In this case, it is likely the device interacted with the heavily calcified, mildly tortuous and 90% stenosed lesion causing the reported failure to advance and subsequent shaft kink.Further handling and/or manipulation of the device during removal likely resulted in the reported shaft separation.Additionally, the guide wire exit notch was reported to be stretched and torn after removal likely due to interaction with the guide wire during the procedure.The separation occurred outside of the body and the device was removed without issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial medwatch report, the following information was received: after removal of the stent delivery system, the guide wire exit notch was noted as stretched and torn.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: 15791166
• MDR Text Key: 307010134
• Report Number: 2024168-2022-11549
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• 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: 2050441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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