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

Model Number	S-60-060-120-P6
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the left popliteal artery.The vessel diameter was 6.00mm and the vessel was prepped with a 6.00x120mm balloon for 2 minutes at 10 atmospheres (atm).A 6.00x55cm sheath and a 18 command st guidewire were used.The 6.00x60mm supera self-expanding stent system (sess) was advanced to the target lesion; however, the stent appeared to have difficulty deploying.The thumb slide moved without resistance.The physician continued to advanced the thumbslide and the stent eventually deployed without further issue.The stent was confirmed to be fully opposed to the vessel wall and the delivery system was removed under fluoroscopy.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 identified no other incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.Report indicates a 6mm diameter left popliteal artery that was predilated with a 6.00x120mm balloon for 2 minutes at 10 atmospheres of pressure through a 6fr x55cm sheath over a command st guide wire.6.0 x 60mm was advanced to target lesion without issue.Report indicates difficulty deploying as the physician advanced the thumb-slide until the stent eventually deployed without issue.Under fluoroscopy, the report states the physician confirmed fully opposed stent and delivery system removed intact.No adverse patient effect and no significant delay noted.An attached link to a screen capture video was included in the complaint showing most of the stent deployed distally in the popliteal artery.As the delivery system is retracted back to uncover the rest of the stent and the thumb-slide is advanced, it does appear to ¿stall¿ or be delayed as the operator continues to manipulate the stent delivery system until the operator eventually was able to release the stent fully opposed to vessel wall confirmed via fluoroscopy.With the media submitted, information provided from the complaint confirming a reasonable approach to pretreat the lesion and reasonable equipment used, there does appear to be an issue with the device.While the device did deliver the stent to the intended target lesion fully opposed, there is evidence that the device did malfunction as there was a delay/difficulty in deploying the stent.The reason for malfunction of the device cannot be determined.Potential causes for activation failure include, but are not limited to, manufacturing, anatomical conditions; deployment technique and/or damage to the device deployment mechanisms (handle components/shaft lumens/ratchet), or inadequate pre-dilatation of the stricture.It is possible that during stent deployment interaction with the anatomy and/or other devices resulted in the ratchet being unable to properly engage/fully deploy the stent; thus, resulting in reported difficult or delayed activation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 15874376
• Report Number: 2024168-2022-11948
• Device Sequence Number: 14814140
• Product Code: NIP
• UDI-Device Identifier: 08717648211805
• UDI-Public: 08717648211805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/28/2022

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: 08/31/2024
• Device Model Number: S-60-060-120-P6
• Device Catalogue Number: S-60-060-120-P6
• Device Lot Number: 2090961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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: 018 COMMAND GUIDE WIRE; 6.00X55CM COOK INTRO SHEATH
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 113 KG