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

Catalog Number	S-60-100-120-P6
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery with no tortuosity, calcification and 50% stenosis.Access in the right groin was obtained using a 6fr sheath, a non-abbott 0.18 guide wire and non-abbott support catheter.Additional access was obtained in the left foot for advancing a non-abbott 0.018 guide wire.The vessel was pre-dilated with an unspecified 6x100mm balloon device.Advancing retrograde, the first supera self expanding stent system (sess) was advanced to the lesion and the stent was deployed.The 6x100mm 120mm supera stent was then implanted in the target lesion in an overlapping fashion.An unspecified post dilation device was advanced, and the second stent was noted to have shifted; therefore, a third supera stent was implanted to cover the gap between the two previous supera stents.Prior to reinserting the dilation device, the device it was reported that the procedure was performed to treat a lesion in the superficial femoral artery with no tortuosity, calcification and 50% stenosis.Access in the right groin was obtained using a 6fr sheath, a non-abbott 0.18 guide wire and non-abbott support catheter.Additional access was obtained in the left foot for advancing a non-abbott 0.018 guide wire.The vessel was pre-dilated with an unspecified 6x100mm balloon device.Advancing retrograde, the first supera self expanding stent system (sess) was advanced to the lesion and the stent was deployed.The 6x100mm 120mm supera stent was then implanted in the target lesion in an overlapping fashion.An unspecified post dilation device was advanced, and the second stent was noted to have shifted; therefore, a third supera stent was implanted to cover the gap between the two previous supera stents.Prior to reinserting the dilation device, the device was being flushed when the tip of the second supera delivery nose was noted to be inside the balloon.There was no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis identified that a ratchet ear of the device was separated and not returned.There is the potential the separated portion remains in the anatomy.No additional information was provided.Was being flushed when the tip of the second supera delivery nose was noted to be inside the balloon.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported tip material separation was able to be confirmed.The reported stent migration 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 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 after successful deployment of the 6x100mm 120mm supera stent during removal the tip inadvertently got caught on the deployed stent resulting in the reported stent migration and ultimately resulted in the reported tip material separation/noted tip jacket and inner member separations.Manipulation of the compromised device resulted in the noted device damages (bunched inner member, bunched catheter shaft).Interaction of devices and/or manipulation of the device resulted in the noted ratchet ear break.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
• 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: 19346525
• Report Number: 2024168-2024-06070
• Device Sequence Number: 16815592
• Product Code: NIP
• UDI-Device Identifier: 08717648211829
• UDI-Public: (01)08717648211829(17)250731(10)3082561
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: S-60-100-120-P6
• Device Lot Number: 3082561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR SHEATH; SUPERA STENT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 93 KG