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

Catalog Number S-45-100-120-P6

Device Problems Difficult or Delayed Activation (2577); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 70% stenosed lesion in the superficial femoral artery (sfa).The 4.5x100 supera peripheral self-expanding stent system (sess) was advanced to the target lesion and deployment was attempted, however the stent only deployed approximately a quarter of the way when significant resistance was experienced with the thumbslide.The sess was withdrawn from the anatomy and a non-abbott device was used to successfully complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

Event Description

Subsequent to the initially filed report, additional information was received: the issue was resistance with the thumbslide.The stent was implanted in the patient.No replacement device was used.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam and the reported difficult or delayed activation were unable to be replicated in a testing environment due to the condition of the returned device.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 there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the moderately calcified, mildly tortuous and 70% stenosed anatomy and/or inadvertent mishandling resulted in the noted multiple device damages (bends on the sheath sporadically, multiple bends on the shaft) thus during stent deployment resulted in the reported mechanical jam.Manipulation of the compromised device resulted in the noted bent ratchet ear (likely contributing to the reported difficulties) and ultimately resulted in the reported difficult/delayed activation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: code 3270 was deleted, code 2577 added.

• 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: 17400485
• MDR Text Key: 319885737
• Report Number: 2024168-2023-08070
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648225987
• UDI-Public: 08717648225987
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 08/31/2023

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 Catalogue Number: S-45-100-120-P6
• Device Lot Number: 2100561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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