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

Catalog Number S-70-100-120-P6

Device Problems Material Separation (1562); Stretched (1601); Difficult or Delayed Activation (2577); Deformation Due to Compressive Stress (2889)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal the nosecone tip inadvertently got caught on the deployed stent resulting in the reported difficult or delayed activation.Interaction/manipulation of the compromised device resulted in the reported stretched stent, the reported sheath kink and ultimately resulted in the reported tip material separation.As reported, angiogram was performed however the missing nose cone was not found in the patient.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.

Event Description

It was reported the procedure was to treat a chronic total occlusion of the popliteal and distal superficial femoral artery.The 7.0x100mm supera self expanding stent system (ses) was advanced to the target lesion.It was thought the stent had fully deployed however during removal it was noted the stent was still partially in the sheath and had elongated.During retraction the stent was able to be fully deployed; however since it elongated it was deployed in the target lesion and partially in healthy tissue.After the ses was removed from the patient it was noted the nose cone was missing and the sheath was kinked.Angiogram was performed however the missing nose cone was not found in the patient.As a precaution, doppler was performed to ensure the leg had proper flow, and the flow sounded great.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• 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: 19031397
• MDR Text Key: 339228064
• Report Number: 2024168-2024-04131
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648350627
• UDI-Public: (01)08717648350627(17)250430(10)3050861
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-70-100-120-P6
• Device Lot Number: 3050861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2023
• 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
• Patient Sex: Male