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

Model Number S-50-120-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problem Ischemia (1942)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the severely calcified right superficial femoral artery (sfa).Pre-dilatation was performed.The 5.0 x 120 mm supera stent was implanted.The stent was fully deployed; however, after deployment, the proximal stent recoiled and seemed to twist.The stent delivery system could not be removed.The physician chose to remove the stent delivery system with resistance, rather than send the patient to surgery.The nose cone of the supera stent delivery system separated from the device; however, the stent delivery system was able to be removed.A stenotic area was created, where the stent recoil and twisting occurred.Additional balloon dilatation was performed and the stent was opened.A second 5.0 x 80 mm supera stent was implanted at the proximal stent.A snare device was able to remove the separated nose cone.The procedure ended with all vessels and stents widely patent, and the nose cone removed from the patient.Post procedure, the patient was in stable condition.No additional information was provided.

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 similar incidents and/or complaints from this lot.The reported patient effect of ischemia is listed as potential adverse event associated with the use of the device and is listed in the supera instruction for use (ifu).Although the device was removed against resistance, the procedural circumstances of the tip being entrapped with the stent presented the need to remove the system against resistance.Additionally, the tip detachment appears to have occurred as the delivery system was being removed with the tip entrapped within the twisted portion of the stent.Based on the information provided, a definitive cause for the reported stent deformation resulting in difficulty removing, tip detachment and subsequent patient effects could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9861761
• MDR Text Key: 187412324
• Report Number: 2024168-2020-02738
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: 08717648211775
• 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: 04/15/2020

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: 10/31/2021
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 9111461
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 95