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

Catalog Number 42045150-120

Device Problem Entrapment of Device (1212)

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

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.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 mildly calcified de novo popliteal artery.Via ante-grade access, a command 18 guide wire was advanced to the lesion.Then a 4.5x150mm supera stent was advanced and confirmed deployed under fluoroscopy.The thumb slide was retracted back to the starting position and both system lock and deployment lock were rotated into locked position.While removing the delivery system, resistance was met and it was noted that the catheter tip was caught onto the proximal section of the implanted stent.The system and deployment lock were unlocked and the thumbslide moved forward and again retracted back to the starting position and re-locked the system and deployment lock.However, the section of the catheter tip was again caught onto the proximal section of the implanted stent.The physician proceeded with a contra-lateral femoral access approach, advanced another guide wire past the stent, inflated a 4x100mm armada 18 balloon at the mid section of the stent and eventually managed to remove the delivery system.The stent remained in position with a final angiogram run showing good results.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported entrapment of the device could not be confirmed/ tested as the stent was not returned.There was noted stretching of the inner member with biological materials noted inside and outside the sheath.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 similar incidents reported from this lot.The investigation determined that operational context is the likely cause for the reported difficulties.It is likely that the supera device encountered significant anatomical challenges during the procedure that while attempting to remove the delivery system from the mildly calcified de novo popliteal artery became entrapped.Antegrade access is a different approach used and as noted there were biological materials noted inside and outside the distal portion of the sheath which means that this likely caused difficulties with the catheter tip and stent.The inner member stretching is likely caused by attempting to reset and remove the system a second time.The unexpected action to insert another guidewire and dilate a balloon to remove the delivery system is based on these case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 11667655
• MDR Text Key: 245489453
• Report Number: 2024168-2021-03138
• Device Sequence Number: 1
• Product Code: NIP
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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: 10/31/2021
• Device Catalogue Number: 42045150-120
• Device Lot Number: 9110161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE-COMMAND 18 ST 300CM,; SHEATH-TERUMO 6F
• Patient Outcome(s): Required Intervention