MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 42065200-120

Device Problems Difficult to Remove (1528); Material Separation (1562); Activation Failure (3270)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a mildly tortuous, moderately calcified superficial femoral artery.The lesion was pre-dilated with an unspecified balloon.Using a 0.18 unknown guide wire, it was advanced beyond the 6.5x200mm supera self-expanding stent (ses).The ses was deployed; however, during removal resistance was felt and it was noted the stent did not release from the delivery system.The delivery catheter's tip separated, but after removal, the tip was found to be along the stent.There was no adverse patient effects reported and no clinically significant delay reported.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.

Event Description

Subsequent to the initial report filed it was reported that the resistance felt during removal was with the sheath.No other stent was used.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is likely that during device withdrawal the device tip inadvertently got caught on the deployed stent; thus during device removal resulted in interaction with the sheath.Interaction and/or manipulation of the compromised device ultimately resulted in the reported tip material separation.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18924447
• MDR Text Key: 337910908
• Report Number: 2024168-2024-03446
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648225116
• UDI-Public: (01)08717648225116(17)250831(10)3091261
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P120020
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42065200-120
• Device Lot Number: 3091261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2023
• 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