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

Model Number S-55-150-120-P6

Device Problems Entrapment of Device (1212); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Activation Failure (3270)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The cut stent remains implanted and the device will not be returned for evaluation, as it was reportedly discarded.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 100% stenosed de novo lesion in the left popliteal artery with heavy calcification.The left common femoral artery (lcfa) access was used and the vessel was prepared with a non-abbott balloon that was inflated to 20 atmospheres for 240 seconds.The 5.50x150mm supera self expanding stent system (sess) was advanced to the target lesion.Deployment was initiated and it was thought that the stent was fully deployed; however, it only partially deployed and remained connected to the delivery system.During removal of the session , the stent became stretched.Part of the stent remained in the lesion, with the most proximal stent stretching and being pulled outside the patient.Because part of the stent was sticking out of the access point of the femoral artery, the patient was bleeding, so the stent was cut and the bleeding was able to be stopped.The portion of the stent that remained in the anatomy was implanted 5cm into the target lesion.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information has been provided.

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 did not indicate a lot specific quality issue.The reported patient effect of hemorrhagic event is listed in the supera peripheral stent system instructions for use (ifu) as a potential adverse effect of peripheral percutaneous intervention.As there was no reported damage noted to the device during the inspection prior to use, it is possible that interaction with the heavily calcified and 100% stenosed anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system; thus resulting in reported activation failure/ deployment failure; however this cannot be confirmed.Interaction and/or manipulation of the device during removal of the supera self-expanding stent system likely resulted in the reported stretched stent and the reported entrapment (part of the stent was sticking out of the access point of the femoral artery).The stent was cut and the portion of the stent that remained in the anatomy was implanted 5cm into the target lesion resulting in the reported malposition of device.The reported difficulties possibly caused/contributed to the reported patient effect(s) however a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure as the stent was cut and the bleeding was able to be stopped.H6: medical device problem code 2017 - removed.H6: investigation findings code 114 - removed.Investigation conclusions code 61 - removed.

Event Description

Subsequent to initial reports the following information was provided: it was reported that during deployment the stent stopped coming out of the outer sheath as the thumbslide was advanced under fluoroscopy.

Event Description

N/a.

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 did not indicate a lot specific quality issue.Reportedly, the deployment lock was not unlocked and the thumb slide was not advanced to the most distal position on the handle.It should be noted that the supera peripheral stent system instructions for use states: while maintaining increased magnification from step 3, rotate the deployment lock to the unlocked position.Under fluoroscopy, slowly advance the thumb slide to the distal most position on the handle.The deviation of the ifu appears to have caused/contributed to the reported activation/deployment failure.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that during final stent deployment the deployment lock was not unlocked and the thumb slide was not advanced to the most distal position on the handle; thus resulting in the reported activation/deployment failure.Removal of the supera self-expanding stent system resulted in the reported stretched stent and the reported entrapment (part of the stent was sticking out of the access point of the femoral artery).The stent was cut and the portion of the stent that remained in the anatomy was implanted 5cm into the target lesion resulting in the reported malposition of device.The reported difficulties possibly caused/contributed to the reported patient effects however a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure as the stent was cut and the bleeding was able to be stopped.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: 15136167
• MDR Text Key: 296948669
• Report Number: 2024168-2022-08379
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/13/2022

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 Expiration Date: 02/28/2023
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 1031961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/03/2022; 08/25/2022
• Supplement Dates FDA Received: 08/24/2022; 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 65 KG