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

Model Number S-55-060-120-P6

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976); Migration (4003)

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

Event Date 06/28/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the superficial femoral artery (sfa).A first 5.5x80mm supera stent was implanted without issue.Then a 5.5x60mm supera stent was implanted at the distal sfa.During removal of the delivery system (under no fluoroscopy) when the catheter was pulled back, the nosecone snagged the 5.5x60mm supera stent and pulled the stent into the sheath at which point the nosecone broke off and was lodged in the sheath with a partial amount of the stent; about 1/4 of the stent implant.No resistance was felt when it was pulled back fast (although advised to pull back slowly).The nosecone was pushed out of sheath and landed in the proximal sfa.The delivery system was ultimately able to be removed and the 5.5x60mm supera stent now inadvertently moved to the proximal sfa.Several snare attempts were made to remove the nosecone (about 90 minutes) but were unsuccessful.However, the snare device was able to straighten out (un-invaginate) the 5.5x60mm supera stent as it had been invaginated on itself.Although the stent implant was supposed to be in the distal sfa, it had been pulled to the proximal sfa where the physician deemed it fine as it did not limit the blood flow.A third supera stent was implanted at the sfa without issue.The next day (b)(6) 2022, surgical intervention was performed to successfully remove the nosecone from the anatomy.The nosecone did not move from sfa overnight.Some thrombectomy was performed post surgery.Patient is doing fine post surgery.Hospitalization was prolonged as the separated nosecone was unable to be retrieved from the initial procedure but was the next day.No additional information was provided.

Manufacturer Narrative

Device code (b)(4).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.Reportedly, the delivery system was not removed under fluoroscopy.It should be noted that the supera peripheral stent system instructions for use states: under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.It is undetermined if the deviation of the ifu caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal interaction with the deployed stent resulted in the nose cone inadvertently snagging the 5.5x60mm supera stent and inadvertently pulling the stent into the sheath.Interaction/manipulation of the device resulted in the reported tip separation, the reported stent migration (inadvertently moved to the proximal sfa) and the reported stent deformation (stent invaginated on itself).The treatments appears to be related to the operational context of the procedure as several snare attempts were made to remove the nose cone, the snare device was able to straighten out the stent, a third supera stent was implanted at the sfa without issue, and surgical intervention was performed to successfully remove the nosecone from the anatomy the next day.There is no indication of a product quality issue with respect to manufacture, design 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
• 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: 15053540
• MDR Text Key: 296151373
• Report Number: 2024168-2022-07883
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• 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: 07/19/2022

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: 12/31/2023
• Device Model Number: S-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 2011861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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
• Treatment: 5.5X80MM SUPERA STENT; 6 FRENCH X 55 LENGTH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 47 KG