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

Catalog Number 42050100-080

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

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

H6: 2017 device code clarifier- failure to follow steps / instructions.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was performed to treat a lesion in the popliteal artery with heavy calcification and moderate tortuosity.The vessel was pre-dilated with an unspecified 5mm balloon dilatation catheter (bdc) then the target lesion was pre-dilated with an unspecified 6mm bdc.The 6mm bdc was unable properly prep the proximal part of lesion resulting in an insufficient lumen; however, the 5.0x100mm supera stent self expanding system (sses) was advanced to the lesion and deployed.During deployment, the stent elongated approximately 20% in the proximal part of the lesion and ending in a 7mm polytetrafluoroethylene (ptfe) bypass graft.The first half centimeter of the stent is located in healthy tissue.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.Reportedly, the procedure was performed to treat a lesion in the popliteal artery with heavy calcification and moderate tortuosity.It should be noted that the supera peripheral stent system instructions for use states: precaution: the post-dilated vessel should be at least the size of the stent diameter.If recommended vessel diameter cannot be gained, optimal stent deployment may not be achieved and revised stent sizing should be considered.Additionally, the stent placement ¿ precautions section 6.2 states: failure to predilate the vessel according to table 15 may impair nominal/optimal stent delivery.Furthermore, the warnings section 5.0 states: careful attention should be paid when sizing and deploying the stent to prevent stent elongation.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use as it is likely that insufficient pre-dilatation of the lesion resulted in the reported elongated/stretched stent.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 18831208
• MDR Text Key: 336853675
• Report Number: 2024168-2024-02700
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42050100-080
• Device Lot Number: 3030161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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