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 Remove (1528); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 07/06/2022

Event Type  malfunction  

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.

Event Description

It was reported that the procedure was to treat the proximal to mid right superficial femoral artery (sfa).Pre-dilatation was performed with a 6×150mm unspecified balloon at 20 atmospheres for 180 seconds.Then a supera was advanced (although it met resistance with the sheath, but ultimately reached the lesion) and in an attempt to deploy at the lesion, the stent completely failed to deploy due to the thumbslide having met heavy resistance during sliding.The supera was removed and noted to meet resistance with the sheath again.A non-abbott device was used as a replacement with post-dilatation to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to advance, difficult to remove, mechanical jam and activation/deployment failure were unable to be 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 identified no other incidents from this lot.As the reported difficulties were not confirmed during return analysis, it is possible that the torturous shape of the anatomy resulted in angling the guiding catheter such that during advancement and removal interactions with the guiding catheter resulted in the reported difficult to advance and the reported difficult to remove.Additionally, interactions with the guiding catheter possibly resulted in the thumbslide being unable to properly engage thus resulting in the reported mechanical jam and the reported activation failure/ deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted mechanical jam and the reported activation failure/ deployment failure cannot be determined.The noted kinked proximal outer sheath and the noted multiple bends noted on the outer sheath likely occurred due to inadvertent mishandling and possibly contributed to the reported difficulties; however this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was to treat the proximal to mid right superficial femoral artery (sfa).Pre-dilatation was performed with a 6×150mm unspecified balloon at 20 atmospheres for 180 seconds.Then a supera was advanced (although it met resistance with the sheath, but ultimately reached the lesion) and in an attempt to deploy at the lesion, the stent completely failed to deploy due to the thumbslide having met heavy resistance during sliding.The supera was removed and noted to meet resistance with the sheath again.A non-abbott device was used as a replacement with post-dilatation to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initially filed mdr report, it was confirmed that pre-dilatation was performed with a 6×150mm non-abbott balloon.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: 15080140
• MDR Text Key: 297159648
• Report Number: 2024168-2022-08025
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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: 12/31/2023
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 2012061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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: SHEATH: CROSSROAD 6F,45CM.