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

Model Number S-55-150-120-P6

Device Problems Premature Activation (1484); Difficult to Advance (2920)

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

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported difficult to advance and the reported premature 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 and similar incident review of the reported lot could not be conducted because the lot number was not provided.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the unspecified sheath during advancement resulting in the reported difficult to advance.Interaction /manipulation of the device resulted in the noted device damages (inner member/tip jacket separations, bunched intermember, kinked sheath) and ultimately resulted in the reported premature activation.The treatment appears to be related to the operational context of the procedure as an unspecified snare was used to successfully retrieve the stent.There is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the popliteal artery.A 5.5x150mm supera self-expanding stent system (sess) had resistance with an unspecified introducer sheath during advancement.The stent prematurely released in the anatomy, so an unspecified snare was used to successfully retrieve the stent.An unspecified supera stent was used to successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.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: 12558304
• MDR Text Key: 274220765
• Report Number: 2024168-2021-08787
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 111