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

Catalog Number	S-70-100-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Difficult or Delayed Activation (2577); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other 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 during removal the nosecone tip inadvertently got caught on the deployed stent resulting in the reported difficult or delayed activation.Interaction/manipulation of the compromised device resulted in the reported stretched stent, the reported sheath kink and ultimately resulted in the reported tip material separation.As reported, angiogram was performed however the missing nose cone was not found in 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.
Event or Problem Description
It was reported the procedure was to treat a chronic total occlusion of the popliteal and distal superficial femoral artery.The 7.0x100mm supera self expanding stent system (ses) was advanced to the target lesion.It was thought the stent had fully deployed however during removal it was noted the stent was still partially in the sheath and had elongated.During retraction the stent was able to be fully deployed; however since it elongated it was deployed in the target lesion and partially in healthy tissue.After the ses was removed from the patient it was noted the nose cone was missing and the sheath was kinked.Angiogram was performed however the missing nose cone was not found in the patient.As a precaution, doppler was performed to ensure the leg had proper flow, and the flow sounded great.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 19031397
• Report Number: 2024168-2024-04131
• Device Sequence Number: 15214308
• Product Code: NIP
• UDI-Device Identifier: 08717648350627
• UDI-Public: (01)08717648350627(17)250430(10)3050861
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: S-70-100-120-P6
• Device Lot Number: 3050861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male