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

Model Number S-65-150-120-P6

Device Problems Product Quality Problem (1506); Material Separation (1562)

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

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

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 that the procedure was to treat a 100% stenosed, de novo lesion with chronic total occlusion in the superficial femoral artery (sfa) with heavy calcification and mild tortuosity.Pre-dilatation was performed with a 5.0 x 240mm non-abbott balloon catheter and a 6.0 x 60mm non-abbott stent was implanted distal to the target lesion.Subsequently, a 6.50 x 120mm supera stent was implanted proximal to the non-abbott stent.Then a 6.5 x 150 supera self expanding stent system (sess) was deployed at the proximal end of the target lesion; however the tip of the sess separated during deployment.Although the separated tip remained on the guidewire, a snare device was used to remove the separated tip.Post-dilatation was completed with a non-abbott balloon, ending the procedure.The physician stated the structure of tip was too weak.There was no clinically significant delay was reported.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

The reported information was reviewed; however, the device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents reported for this lot.Potential causes for tip detachment include, but are not limited to, anatomical conditions, withdrawal technique, incorrect vessel sizing, and incomplete stent deployment prior to withdrawal, inadequate pre-dilation of the target vessel, manufacturing, or materials related.The investigation was unable to determine a conclusive cause for the reported tip separation and tip structure too weak.However, the reported treatment appears to be related to the operational context of the procedure as a snare device was used to help remove the separated tip.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: 13482049
• MDR Text Key: 285246701
• Report Number: 2024168-2022-01286
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: 08717648226328
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: S-65-150-120-P6
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 1030861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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