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

Catalog Number 42060120-120

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

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

Event Date 07/31/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The 6.0x120mm supera stent self-expanding stent system (sess) was advanced to the target lesion and the stent was released; however, three attempts [excursions] had to be made to lock the delivery system.Then when retracting the delivery system of the tip of the sess became stuck and separated in the stent during removal.A snare device was used to remove the separated tip, and the procedure was completed.There was no adverse patient sequela.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.

Manufacturer Narrative

H6: medical device problem code 2017 clarifier- incorrect removal.The device was not returned for analysis.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.Reportedly, the thumb slide was fully retracted to the start position but both the system and deployment levers were not locked prior to removal.It should be noted that the supera peripheral stent system instructions for use states: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.Although it was noted that the system and deployment levers were not locked prior to removal, this was due to the tip becoming stuck in the deployed stent.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after stent deployment during device removal the tip of the device inadvertently became stuck in the deployed stent resulting in the reported difficult or delayed activation (unable to lock the system and deployment levers) and the reported difficult to remove.Manipulation of the compromised device ultimately resulted in the reported tip material separation.The treatment appears to be related to the operational context of the procedure as reportedly a snare device was used to remove the separated tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Additional information: the procedure was to treat a 90% stenosed lesion in the superficial femoral artery (sfa) with moderate calcification.After the stent was implanted, the thumb slide was retracted, but not put in the locked position prior to removal of the device due to the tip separation.No additional information was provided.

• 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: 17624790
• MDR Text Key: 321967013
• Report Number: 2024168-2023-09315
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42060120-120
• Device Lot Number: 2102061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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
• Treatment: 6F, 11CM SHEATH; BOSTON V18 GUIDE WIRE
• Patient Outcome(s): Required Intervention