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

Model Number S-45-060-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.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 investigation determined the reported difficulties appear to be related to circumstances of the procedure and deviation of the instructions for use as it is likely that prior to removal the thumb slide was not fully retracted to the starting position and the system lock and deployment lock were not in the locked position; thus during removal the tip inadvertently got stuck on the deployed stent strut resulting in the reported difficult to remove.Manipulation of the compromised device ultimately resulted in the reported tip separation/noted tip jacket and inner member separation.As reported, the nosecone was unable to be removed from the location.The nosecone remains in the peroneal artery; however, the artery was confirmed to be patent.Reportedly, during removal under fluoroscopy the red levers were not locked before the catheter was being pulled out.It should be noted that the supera peripheral stent system instructions for use (ifu) states: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.The deviation of the ifu appears to have possibly contributed to the reported difficulties.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 the popliteal and distal femoral artery (sfa) via a direct stick to the popliteal through a bypass graft.The vessel diameter was 4-4.5mm, and the atherectomy was not used.During preparation of a 4.5x40mm supera self expanding stent (sses) the nosecone appearance did not like how it looked therefore was not used in the patient.Another 4.5x60mm supera sses was prepared, and the vessel was prepared with a balloon dilatation.The stent was deployed; and during removal under fluoroscopy, the red levers were not locked before the catheter was being pulled out, the nosecone got stuck on the stent strut and then detached.The nosecone was unable to be removed from the location.The delivery system was removed under fluoroscopy.The nosecone remains in the peroneal artery; however, the artery was confirmed to be patent.There were no reported adverse patient sequela.No additional information was provided.Returned device analysis of the 4.5x40 supera sess identified a separated tip which was not returned.The account stated it was likely discarded.

• 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: 16354389
• MDR Text Key: 309303574
• Report Number: 2024168-2023-01380
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648225949
• UDI-Public: 08717648225949
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-45-060-120-P6
• Device Catalogue Number: S-45-060-120-P6
• Device Lot Number: 2090761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• 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 PINNACLE SHEATH
• Patient Outcome(s): Hospitalization
• Patient Sex: Male