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

Model Number S-50-120-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Difficult or Delayed Activation (2577); Defective Device (2588); Material Deformation (2976)

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

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a de-novo lesion in the heavily calcified, heavily tortuous right superficial femoral artery.Non-abbott balloons were used for pre-dilatation.A 5x120mm supera self-expanding stent system (sess) was advanced, and the stent was deployed.However, during removal, it was noted that the stent had been partially deployed in the non-abbott sheath.The stent elongated, shrank, and became invaginated in multiple areas and was difficult to remove into the sheath.The sheath was able to be removed, which allowed the stent to be fully deployed.After removal, it was noted that the tip of the sess separated, so an unspecified guide wire and balloon were used to successfully remove the separated portion and complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficult or delayed activation, stent elongation, stent shortened, material deformation and difficult to remove could not be confirmed or replicated due to the condition of the returned device, as the stent was already fully deployed.The tip separation 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 identified no other complaints reported from this lot.The investigation determined that the reported difficulties were most likely related to case circumstances.It is likely that during deployment the stent elongated causing partial deployment into the non-abbott introducer sheath.The elongation likely occurred due to challenging anatomical conditions which were reported as heavily calcified and heavily tortuous.The additional elongation, invagination, shortening of the stent and tip detachment likely occurred as manipulation with the introducer sheath occurred when the sheath was being removed with the stent partially deployed within it.The unexpected medical intervention to snare the separated tip was due to circumstances of the procedure.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
• MDR Report Key: 12186217
• MDR Text Key: 262167693
• Report Number: 2024168-2021-06159
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: 08717648211775
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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: 11/30/2021
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 9120361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/17/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention