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

Model Number S-65-080-120-P6

Device Problems Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Difficult to Advance (2920)

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

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

It was reported that the procedure was to treat a short thrombotic lesion from the common femoral artery (cfa) to the superficial femoral artery (sfa).The target lesion was a de novo lesion with eccentric stenosis.The vessel diameter was 6.5mm, and the lesion length was 50mm.A trans ankle approach was taken and pre-dilatation was performed.The 6.5x80 mm supera self expanding stent system (sess) was deployed from the sfa ostium to cfa.The thumb slide was pulled back to proximal side and the delivery system was attempted to be removed outside the patient body; however, it was stuck with the supera stent.Force was applied in attempt to remove the delivery system, and the thumb slide was pulled back to proximal side; however, the nose cone was stuck to the proximal edge of the stent.At this point the physician suspected proximal stent edge malapposition.Therefore, the guiding sheath was advanced to be close to the nose cone, it covered the nose cone and the system was able to be removed from the body.Next, a balloon dilatation catheter (bdc) was advanced to dilate at the proximal edge of the stent, but there was resistance near the proximal edge of the stent and the bdc could not be advanced.Force was applied and the bdc then could advance and be inflated.The supera stent was confirmed to have enough apposition by fluoroscopy.Next, intravascular ultrasound (ivus) was advanced, but it could not advance past the proximal edge of the stent.Again, a bdc was attempted, but it also could not cross the stent.The physician determined it was not safe to leave the stent in place.Therefore, the stent was attempted to be grasped with forceps to be removed; however, it could not be pulled into the guiding sheath.The stent stretched to the anterior tibial artery (ata), and remains partially in the target lesion while stretched to the ata.Blood flow at the ata was poor before this procedure, and remains poor.No additional information was provided.

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 did not indicate a lot specific quality issue.A cine was received and reviewed by an abbott vascular clinical specialist.The movie clip confirmed that the delivery system of the supera stent was unable to be removed from the deployed stent as intended.Reportedly, force was applied in attempt to remove the delivery system, and the thumb slide was pulled back to proximal side; however, the nose cone was stuck to the proximal edge of the stent.It should be noted that the supera instruction for use states: should unusual resistance be felt at any time during stent system advancement or stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Although it was noted the physician used force in the attempts to remove the device, this was due to the nose cone being stuck to the proximal edge of the stent, therefore the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.The delivery system was removed by advancing the introducer sheath over the nose cone (tip of the catheter delivery system).The delivery system was then able to be removed.The events to deliver the balloon catheter and the ivus catheter as well as the attempt to remove the stent with forceps was not within the movie clip provided.Thus, these events cannot be confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the deployed stent as the tip/nose cone was being retracted resulted in the reported difficult to remove.Manipulation in attempts to withdraw the device resulted in the reported wall apposition/proximal stent edge malposition.Interaction with the proximal edge of the stent in attempts to advance a balloon dilatation catheter and a intravascular ultrasound (ivus) resulted in the reported difficult to advance.Unsuccessful attempts to remove the stent with forceps resulted in the reported stretched stent.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 12514552
• MDR Text Key: 272761274
• Report Number: 2024168-2021-08453
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226267
• UDI-Public: 08717648226267
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: S-65-080-120-P6
• Device Catalogue Number: S-65-080-120-P6
• Device Lot Number: 0072961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention