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

Catalog Number 42055060-120

Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601)

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

Event Date 01/03/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat an 80% stenosed de novo lesion in the superficial femoral artery with moderate calcification and moderate tortuosity.A command 18 st guidewire crossed the lesion and pre-dilatation was performed with a 6x40mm armada balloon.The 5.5x60mm supera self-expanding stent system (sess) was attempted to be used in the procedure; however, during deployment the stent became stretched.During removal of the delivery system resistance was noted and the nose cone became separated from the sess.The stent was deployed in the target lesion and the nose cone was snared from the patient.There was no adverse patient sequela.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 stretched stent were unable to be replicated in a testing environment as they was based on operational circumstances.The lot history record (lhr) 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 stretched stent and ultimately resulted in the reported tip separation/noted tip jacket and inner member separations and the noted bent stabilizing shaft.As reported, the stent was deployed in the target lesion and the nose cone was snared from the patient.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: 18545183
• MDR Text Key: 333269032
• Report Number: 2024168-2024-00992
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648224959
• UDI-Public: (01)08717648224959(17)250531(10)3060661
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42055060-120
• Device Lot Number: 3060661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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): Required Intervention