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

Catalog Number 42055150-120

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

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

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned.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 to treat a moderately calcified, 50% stenosed lesion in the distal superficial femoral artery (dsfa).The lesion was pre-dilatated with non-abbott balloons, and a 5.5x150mm supera peripheral self-expanding stent system (sess) was advanced.The stent was implanted without issue.Upon removal of the sess from the anatomy, resistance was met and the nose cone separated and remained in the guiding sheath.The guiding sheath was attempted to be removed with the nose cone; however, upon passing through the iliac artery, the nose cone dislodged from the guiding sheath.A snare was used to capture the nose cone.During removal of the snared nose cone, the implanted stent was removed as well as the nose cone was attached to the implanted stent.A new 5.5x150mm supera stent was implanted to complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported tip material separation was able to be confirmed.The reported difficult to remove and the reported stent migration was unable to be replicated in a testing environment as they were based on operational circumstances.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.A cine was received and reviewed by an abbott vascular clinical specialist.In conclusion: the incident report states that during the deployment of a 5.5 x 150 mm supera self-expanding stent the nose cone of the stent delivery system separated, requiring retrieval via snaring.The provided media (cine video) displays a supera stent in the process of deployment in a calcified femoral artery.During stent deployment the nose cone is initially moving as expected but then becomes stuck within the stent while the stent delivery system continues to retract.The media confirms the incident report description that the nose cone separated from the stent delivery catheter.No probable cause for the nose cone separation can be determined from the provided media.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 during system removal interaction of the deployed stent with the nose cone inadvertently resulted in the reported difficult to remove.Manipulation of the device ultimately resulted in the reported tip separation/noted tip and inner member separations.The treatment appears to be related to the operational context of the procedure as reportedly a snare was used to capture the nose cone and thus inadvertently resulted in the reported stent migration as the nose cone as was attached to the implanted stent during removal.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 16503933
• MDR Text Key: 310893816
• Report Number: 2024168-2023-02378
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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: 42055150-120
• Device Lot Number: 2090661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2022
• 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 - 200 MM STANDARD BALLOON.; 5 - 200 MM ULTRASCORE BALLOON.; 6 F SHEATH.; 9 F SHEATH.
• Patient Outcome(s): Required Intervention