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 Stretched (1601); Activation Failure (3270); Migration (4003)

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

Event Date 08/31/2022

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, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified, moderately tortuous and 99% stenosed anatomy resulted in the ratchet being unable to fully release the stent from the delivery system; thus resulting in reported activation failure/deployment failure.During removal interaction between the sheath and the partially deployed stent resulted in the reported stretched stent and ultimately resulted in the reported stent migration as the elongated stent was noted to remain partially in the cfa and partially in the external iliac artery.As reported, the procedure was concluded without further treatment and no intervention required.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 99% stenosed lesion in the left common femoral artery (cfa).A 5.5x150mm supera self-expanding stent system (sess) was advanced to the target lesion and the stent deployed.Under fluoroscopy, it was thought that the stent was completely out of the sheath of the device; however, during removal of the sess, the stent became elongated and was pulled into the external iliac artery.After the delivery system finally released the stent, the elongated stent was noted to remain partially in the cfa and partially in the external iliac artery, but well apposed to the vessel wall.The delivery system was successfully removed from the anatomy and the procedure was concluded without further treatment.No additional intervention was required.There was no adverse patient effect 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: 15491252
• MDR Text Key: 303243653
• Report Number: 2024168-2022-10020
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2022

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: 12/31/2022
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 1012761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 64 KG