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

Catalog Number 42045040-080

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult or Delayed Activation (2577); Difficult to Advance (2920)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 08/15/2023

Event Type  Injury  

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.The reported patient effect of occlusion is listed in the supera peripheral stent system instructions for use as a potential adverse event associated to the use of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily tortuous anatomy resulting in the reported difficult to advance.During deployment the tip/nose cone inadvertently got caught on the end of the stent resulting in the reported difficult/delayed activation/deployment and the reported difficult to remove.Interaction/manipulation of the compromised device ultimately resulted in the reported tip material separation.The reported difficulties possibly caused/contributed to the reported patient effects; however, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.As reported, the tip was left floating in healthy artery.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) distal to a bypass in the left leg with heavy tortuosity.Atherectomy was not used.Pre-dilatation was performed on the distal anastomosis that was tortuous with a 5mm balloon.No visible waisting was noted during the pre-dilatation.The 4.5x40mm supera self-expanding stent system (sess) crossed the anastomosis and the stent deployed normally but narrowed at the anastomosis trapping the catheter tip on the distal side of the narrowing.The rest of the supera stent was continued to be deployed until there was a few millimeters left to deploy and the catheter moved/jumped forward causing the last few millimeters to retract.The thumb slide was slid back and the locks were locked to remove the catheter but the tip snapped from the catheter distal to the narrowing as it was pulled back.There were no issues with the deployment mechanism.There was minimal resistance during advancement and removal.The delivery system was removed under fluoroscopy.Minimal force was also applied and the nose cone detached without much pulling.The delivery system caught the end of the stent enfolding it proximally and the nose cone getting caught.An unspecified catheter managed to cross the deployed supera which was used to push the tip into the posterior tibial artery.The tip was left floating in healthy artery and occluded it.There was no additional treatment performed.Final angiograms showed flow through the supera stent and fast flow to the foot.The left groin was closed with a vascular closure system.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.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: 17683600
• MDR Text Key: 322642587
• Report Number: 2024168-2023-09598
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42045040-080
• Device Lot Number: 2121361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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
• Treatment: 6F 11CM INTRODUCER SHEATH; BOSTON V18 0.018" GUIDEWIRE.
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG