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

Catalog Number 42075060-120

Device Problems Break (1069); Stretched (1601); Device Damaged by Another Device (2915)

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

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Unique device identifier (udi#): in the absence of a reported part and lot numbers, the udi cannot be calculated.Implant date estimated.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported at the end of (b)(6) an unspecified supera self-expanding stent was deployed in the common femoral artery.The stent ended distally just above the origin of the superficial femoral artery (sfa)/profunda.On (b)(6) 2021, the patient returned for intervention in the popliteal artery.An ultrasound-guided antegrade puncture was performed through the struts of the deployed supera stent with a 6f sheath.After puncturing and probably by introducing the sheath, it was found that the distal part of the deployed stent had elongated and extended into the proximal part of the sfa.Additionally, a small piece of supera wire had become loose from the distal part of the stent.This proximal part of the sfa, with the extended part of the deployed supera stent, gave a messy image after imaging by iodine contrast.An unspecified absolute pro self-expanding stent was placed from the origins to beyond the extended part of the deployed supera to include the partially detached piece of the supera stent.Good results were achieved.There was no clinically significant delay in the procedure.No additional information was provided.

Event Description

Additional information: it was reported the 7.5x60mm supera self-expanding stent was deployed on (b)(6) 2021 in the common femoral artery (cfa).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 identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction as the deployed supera stent was punctured and the 6f sheath was introduced through the puncture resulted in the reported device damaged by another device.Interaction/manipulation of devices resulted in the reported supera stent damages (stretched, break).The treatment appears to be related to the operational context of the procedure as an unspecified absolute pro self-expanding stent was placed from the origins to beyond the extended part of the deployed supera to include the partially detached piece of the supera stent.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: 12259477
• MDR Text Key: 264508584
• Report Number: 2024168-2021-06700
• Device Sequence Number: 1
• Product Code: NIP
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 42075060-120
• Device Lot Number: 1022461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6F; SHEATH: 6F
• Patient Outcome(s): Required Intervention