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 Device Dislodged or Dislocated (2923); Activation Failure (3270)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, the complaint history was reviewed and there is no indication of a lot specific product quality issue.The investigation determined that anatomical conditions resulted in the report difficulties.It is likely that the reported difficulties were due to the heavily calcified lesion in the popliteal artery.Additionally, it is likely that the distal sheath of the delivery system was entrapped or bent in the anatomy due to limited clearance such that the ratchet was unable to properly engage the stent during the final positioning, consequently the stent released from the delivery system while in the introducer sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The barewire workhorse device referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a heavily calcified lesion in the popliteal artery.A workhorse bare wire was advanced past the guiding catheter; however, it became stuck with the anatomy.The bare wire was being removed and resistance with the anatomy was felt.Once outside the anatomy it was noted that the tip coils were stretched.A non-abbott guide wire was advanced.Following pre-dilatation, a 5.5x150mm supera self-expanding stent was deployed per the instructions for use; however, the stent could not release from the delivery system.The deployment lock was unlocked and the thumb slide advanced to the most distal position on the handle again and still the stent would not fully release.The stent and delivery system were being removed under fluoroscopy and the stent released from the delivery system while in the introducer sheath, no resistance was felt.The sheath was removed and it was verified that the stent was in the sheath.The procedure was successfully completed with a non-abbott stent.There were no adverse patient effects 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: 11324174
• MDR Text Key: 233111926
• Report Number: 2024168-2021-01169
• 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: 02/12/2021

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 Expiration Date: 07/31/2021
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 9082961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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 Age: 69 YR