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

Model Number S-60-120-120-P6

Device Problems Difficult or Delayed Activation (2577); Defective Device (2588)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a de novo, concentric stenosis in a heavily calcified and mildly tortuous superficial femoral artery (sfa) using a cross-over approach.The vessel diameter was 6 mm and pre-dilatation was performed with a non-abbott device at a pressure of 20 atmospheres (atms) for 60 seconds.Atherectomy was not used.The 6.0x120mm supera self expanding stent system (sess) was attempted to deploy but the stent only partially released.The system was pulled under fluoroscopy for troubleshooting and the stent was able to be released gradually responding with the thumb slide but took more time than usual, however, there was no problem in the deployment mechanism.It was also noted that the deployed stent was 2 cm shorter than intended but fully covered the lesion.There were no concerns with the location or condition of the deployed stent as it fully covered the lesion and did not move from the deployed location and completed the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned for analysis.The reported difficult or delayed activation and the reported defective device shortened were unable to be replicated in a testing environment as the component was not returned.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 as it is likely that during stent deployment interaction with the heavily calcified and mildly tortuous anatomy and/or other devices resulted in the ratchet being unable to properly engage/fully deploy the stent; thus resulting in reported difficult or delayed activation.Additionally, as the stent was ultimately being deployed it is likely that the delivery system was slightly pushed distally resulting in the reported deployed stent being 2 cm shorter than intended.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 13498451
• MDR Text Key: 288786435
• Report Number: 2024168-2022-01337
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 1040162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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: VASALLO NS3, 0.014INCH GUIDE WIRE