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

Catalog Number 42065080-120

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

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after successful stent deployment when removing the delivery system the tip inadvertently got caught on the deployed stent, thus resulting in the reported resistance noted at the introducer sheath during removal and ultimately resulting in the reported activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat the superficial femoral artery with moderate calcification, moderate tortuosity and 80% stenosis.The lesion was pre-dilated with a 7 mm balloon for 3 minutes at nominal pressure and atherectomy was not performed.The 6.5x80 mm supera self expanding stent system (sess) was advanced to the correct placement of the lesion.The stent was deployed; however, when removing the delivery system, resistance was noted at the introducer sheath.During angiography it was found that the stent had been pulled back to the introducer sheath.The stent, delivery system and introducer sheath were removed together as one unit.Outside of the patient it was noted that the delivery system was stuck behind the stent and pulled everything out with it when it was removed.A new 6fr sheath was advanced over the guide wire and a 6.5x100 mm supera stent was deployed at the intended location without any issues.There were no adverse patient effects and there was no clinically significant delay in the procedure.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: 18136841
• MDR Text Key: 328166091
• Report Number: 2024168-2023-12677
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42065080-120
• Device Lot Number: 3020161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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
• Treatment: 0.018 GUIDE WIRE; 6FR SHEATH