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

Model Number S-55-120-120-P6

Device Problems Material Separation (1562); Stretched (1601); Activation Failure (3270)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported this was a procedure to treat a moderately calcified posterior superficial femoral artery.It was noted that imaging was very challenging, and the vessel was not prepped prior to inserting the supera 5.5x120.The supera was able to reach the target lesion and was attempted to be deployed.However, during deployment, it was observed the stent started to elongate into the bifurcation of the femoral artery.The nose cone then became caught on the sheath, but due to challenging imaging, the physician was unable to see this issue.The deployment sequence was continued, but it was observed the nose cone detached and migrated to the bifurcation.Although the nose code detached, it became stuck on the sheath and was no longer mobile.Since the stent was not deployed, the physician was able to remove the stent delivery system and the sheath.All devices were removed from the anatomy and the physician replaced the supera with a non-abbott device.Once removed, it was observed the stent was partially deployed in the sheath.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported this was a procedure to treat a moderately calcified posterior superficial femoral artery.It was noted that imaging was very challenging, and the vessel was not prepped prior to inserting the supera 5.5x120.The supera was able to reach the target lesion and was attempted to be deployed.However, during deployment, it was observed the stent started to elongate into the bifurcation of the femoral artery.The nose code then became caught on the sheath, but due to challenging imaging, the physician was unable to see this issue.The deployment sequence was continued, but it was observed the nose code detached and migrated to the bifurcation.Although the nose code detached, it became stuck on the sheath and was no longer mobile.Since the stent was not deployed, the physician was able to remove the stent delivery system and the sheath.All devices were removed from the anatomy and the physician replaced the supera with a non-abbott device.Once removed, it was observed the stent was partially deployed in the sheath.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the vessel was prepped where the stent was intended to land.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported activation failure and stent elongation could not be confirmed.The tip detachment was confirmed.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 revealed no other complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the vessel diameter was smaller than the stent outer diameter resulting in elongation and causing the stent to partially deploy into the sheath.In addition, it is likely that the tip separation occurred as the thumbslide was being retracted and the tip was retracted into the narrowed portion of the stent which was partially deployed in the sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 13018392
• MDR Text Key: 282336706
• Report Number: 2024168-2021-11666
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226144
• UDI-Public: 08717648226144
• 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,Followup
• Report Date: 01/25/2022

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 Expiration Date: 07/31/2022
• Device Model Number: S-55-120-120-P6
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 0081361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• 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
• Treatment: SHEATH