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); Difficult to Advance (2920); Material Deformation (2976); Activation Failure (3270)

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

Event Date 05/03/2022

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 did not indicate a lot specific quality issue.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 anatomy resulted in the reported difficult to advance/position and thus resulting in the ratchet being unable to properly engage and release the stent from the delivery system resulting in reported activation failure/ deployment failure.During deployment interaction with the heavily calcified anatomy resulted in the reported stretched and material deformation (stent elongated and almost completely fully collapsed).There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure the right superficial femoral artery (sfa) with heavy calcification.Access was from the left femoral artery.Atherectomy was performed.The 5.5x150mm supera self-expanding stent (sess) was advanced to the target lesion with difficulty due to the anatomy.During deployment, the the stent elongated and almost completely fully collapsed and the stent partially deployed.The sess, including the stent, was removed without issue.There was no adverse patient effect and no clinically significant delay reported.Another same size supera was used to successfully complete 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: 14479552
• MDR Text Key: 292493454
• Report Number: 2024168-2022-05541
• 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: 05/23/2022

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: 08/31/2022
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 0091561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 91 KG