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

Model Number S-55-150-120-P6

Device Problems Stretched (1601); Improper or Incorrect Procedure or Method (2017); Migration (4003)

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

Event Date 06/16/2022

Event Type  Injury  

Event Description

It was reported that this was a procedure performed to treat a target lesion in the superficial femoral artery (sfa)/profunda artery bifurcation.Vessel access was via the popliteal artery.The supera stent delivery system was placed at the target lesion, without fluoroscopy.No difficulty was noted during stent deployment; however, the stent was deployed quickly, resulting in the stent elongating more than 10%.Due to the length of the target lesion, two additional supera stents were implanted proximal to the first, in overlapping fashion and fully covering the target lesion.Post dilatation was performed, using an 8.0 x 40 mm dilatation catheter.The dilatation catheter was advanced through the proximally placed supera stents; however, when advancing through the first supera stent, the dilatation catheter seemed to be catching on the stent.Force was applied to advance the dilatation catheter, resulting in the supera stent being pushed out of position, so that it jailed the profunda artery.Additional post dilatation was performed, and this seemed to help with some of the stent elongation; however, the profunda artery remained partially jailed.No portion of the target lesion was left untreated and no additional intervention was performed.There was no adverse patient sequela and no clinically significant delay.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 incidents from this lot.Reportedly, the supera stent delivery system was placed at the target lesion, without fluoroscopy.It should be noted that the supera peripheral stent system instructions for use (ifu) states: implantation of the supera stent should be performed only under fluoroscopic observation with radiographic equipment providing high resolution images.Additionally, reportedly the stent was deployed quickly; as a result, the stent elongated more than 10%.It should be noted that the ifu states: under fluoroscopy, continuously and slowly retract and advance the thumb slide multiple times.Each full advancement of the thumb slide will only deploy a short section of the stent.Shorter thumb slide advancements may provide greater control versus full thumb slide advancements.The investigation determined the reported difficulties appear to be related to deviation of the ifu and subsequent circumstances of the procedure as it is likely that the stent was deployed too quickly resulting in the reported stretched stent.During post dilatation the dilatation catheter was catching on the stent; thus, manipulation using force to advance the dilatation catheter resulted in the reported stent migration.The treatment appears to be related to the operational context of the procedure as post dilatation was performed and this helped with the stent elongation.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
• 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: 14977926
• MDR Text Key: 295625292
• Report Number: 2024168-2022-07452
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2022

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 Expiration Date: 02/29/2024
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 2033061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male