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

Model Number S-55-150-120-P6

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.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 form this lot.Based on the information provided, a definitive cause for the tip detachment could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat an unspecified lesion.The stent was deployed but it was not specified if in the target lesion or healthy tissue.The 5.5x150mm supera tip separated and was then removed using a snare device.A non-abbott stent was then deployed in the supera stent.There was no adverse patient sequela reported.No additional information was provided.

Event Description

It was reported that the procedure was performed to treat an unspecified lesion.The stent was deployed but it was not specified if in the target lesion or healthy tissue.The 5.5x150mm supera tip separated and was then removed using a snare device.A non-abbott stent was then deployed in the supera stent.There was no adverse patient sequela reported.Subsequent to filing the initial report a user facility medwatch report was received that states, "doctor deployed the 5.5x150mm abbott vascular supera stent in the superior femoral artery to popliteal artery.After the stent was deployed the doctor tried to remove the nose cone and it got caught on the stent.The nose cone detached from the device.Doctor then used a 6fr snare and removed all of the nose cone." no additional information was received.

Manufacturer Narrative

Attachment medwatch report #3600510000-2020-8014na.

• Brand Name: SUPERA PERIPHERAL 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: 10271841
• MDR Text Key: 198755731
• Report Number: 2024168-2020-05785
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

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: 02/28/2022
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 0030961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 65