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

Model Number S-60-150-120-P6

Device Problems Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 07/07/2022

Event Type  malfunction  

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 did not indicate a lot specific quality issue.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 calcified and heavily tortuous anatomy resulting in the reported difficult to advance.Additionally, it is likely interaction with the heavily calcified and heavily tortuous anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system; thus resulting in reported activation failure/ deployment failure and the reported mechanical jam.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 de novo lesion in the left superficial femoral artery (sfa) with heavy calcification and heavy tortuosity.Atherectomy was not performed and a 6.00x150mm balloon was used to pre-dilate the 120mm lesion at 24 atmospheres(atm) for 90 seconds.Using the cross-over approach from the right common femoral artery (rcfa) with a 6 fr sheath the 6.00x150mm supera self expanding stent system (sess) was advanced to the target lesion with difficulty due to the anatomy.During stent deployment the sheath was 10cm from the proximal end of the stent.The thumbslide was advanced; however the thumbslide became stuck and the stent only deployed approximately 3cm.Therefore, the sess was removed from the patient under fluoroscopy.The was no adverse patient effect and no clinically significant delay reported.In the physician's opinion the sess met with resistance when crossing the aorta bifurcation.The procedure was completed with a non-abbott stent.No additional information has been 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: 15114517
• MDR Text Key: 298002503
• Report Number: 2024168-2022-08235
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

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: 02/28/2023
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 1031661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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
• Treatment: 90CM DESTINATION 6FR SHEATH