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

Catalog Number S-65-120-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Migration (4003)

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

Event Date 04/02/2024

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with heavy calcification.The 6.0x200mm armada balloon dilatation catheter (bdc) was advanced without resistance to the target lesion for pre-dilatation but ruptured at 12 atmospheres during the first inflation.The balloon was removed without issue and replaced with a new balloon to successfully pre-dilate the lesion.The 6.5x120mm supera self-expanding stent system (sess) was then advanced to the target lesion without resistance and the stent was deployed.There was resistance with the vessel upon removal and something was felt released in the device.No force was applied.When the sheath was removed it was noted that the nose cone had separated.It was also noted that the stent had been caught on the sheath because when performing manual compression the nose cone and stent were felt in the tissue track.The separated nose cone and migrated stent were removed with hemostats from the femoral artery.Nothing remains in the patient.The case aborted and hemostasis was obtained.There was no adverse patient sequelae.There was a delay in the procedure due to manual compression applied for 20 minutes.The patient was sent to another hospital for observation as precautionary and doing fine.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional armada 18 device referenced in b5 is filed under separate medwatch report number.

Manufacturer Narrative

The device was returned for analysis.The reported material separation and the reported stent migration were able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the nose cone inadvertently became caught on the deployed stent resulting in the reported difficult to remove.Interaction/manipulation of the compromised device resulted in the reported stent migration and ultimately resulted in the reported tip material separation/noted tip jacket and inner member separations and the noted mangled stent.As reported, the separated nose cone and migrated stent were removed with hemostats from the femoral artery.Based on the reported information and results of the complaint investigation 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
• 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: 19140307
• MDR Text Key: 340562069
• Report Number: 2024168-2024-04864
• Device Sequence Number: 1
• Product Code: NIP
• 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,Followup
• Report Date: 05/29/2024

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 Catalogue Number: S-65-120-120-P6
• Device Lot Number: 3101161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG