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

Catalog Number 42055080-120

Device Problems Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 10/27/2021

Event Type  Injury  

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 a heavily calcified, moderately tortuous de novo superficial femoral artery (sfa) is that is 95% stenosed.The 5.5x80mm supera self-expanding stent system (sess) was advanced and during deployment of the stent the tip of the sess separated.The sess was only partially deployed as resistance was felt with the thumbslide.An additional retrograde puncture of the popliteal was performed to remove the tip and the supera stent via snare.It was noted the device was removed under fluoroscopy.There was no adverse patient sequela reported and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported activation failure and resistance with the thumbslide could not be confirmed as the stent was already fully deployed.The tip detachment was 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 revealed no other complaints reported from this lot.The investigation was unable to determine a cause for the reported deployment difficulties and tip detachment resulting in unexpected medical intervention to remove the tip and stent.It may be possible that the distal sheath of the delivery system was entrapped or bent in the anatomy causing resistance with the thumbslide and preventing the ratchet ears from engaging the stent properly to allow full release of the stent; however, this could not be confirmed.The tip detachment may be the result of retracting the delivery system with the stent partially deployed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 12882989
• MDR Text Key: 281330835
• Report Number: 2024168-2021-10833
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 42055080-120
• Device Lot Number: 1060861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• 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
• Patient Outcome(s): Required Intervention