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

Model Number	S-60-040-120-P6
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
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.Na.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in an unspecified artery.The 6.0x40mm supera self-expanding stent system (sess) was advanced to the target lesion, however, the delivery system was removed from the anatomy before deployment of the stent and it was noted that the catheter tip was separated.The tip was removed from the anatomy.A 5.0x40mm supera stent was used to complete the procedure.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6- medical device problem code 2017 clarifier: incorrect removal.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 similar incidents from this lot.Reportedly, the thumb slide was not fully retracted to the start position and both the system and deployment levers were not locked prior to removal.It should be noted that the supera peripheral stent system instructions for use (ifu) states: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.It is undetermined if the deviation of the instructions for use conclusively caused and/or contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that that the distal sheath of the delivery system was entrapped or bent in the heavily calcified, moderately tortuous and 90-99% stenosed anatomy such that the ratchet was unable to properly/fully engage the stent resulting in the reported deployment difficulty/activation failure.Interaction and/or manipulation of the device during removal ultimately resulted in the reported tip material separation.As reported, the tip was removed using forceps.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in an unspecified artery.The 6.0x40mm supera self-expanding stent system (sess) was advanced to the target lesion, however, the delivery system was removed from the anatomy before deployment of the stent and it was noted that the catheter tip was separated.The tip was removed from the anatomy.A 5.0x40mm supera stent was used to complete the procedure.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.Subsequent to the initially filed mdr, the following information was provided: the procedure was to treat the distal superficial femoral artery (sfa) to popliteal artery with 90-99% stenosis, heavy calcification and moderate tortuosity.The vessel diameter was 6mm and the vessel was prepared using a non-abbott balloon.Atherectomy was not used.There was no resistance during advancement and the device was partially deployed.There were no issues with the deployment mechanism.The physician did not rotate the system lock and the deployment lock into the locked position (in line with the thumb slide).The thumb slide was not fully retracted to the start position and both the system and deployment levers were not locked prior to removal.There was no resistance during removal.The delivery system was removed under fluoroscopy.The tip was removed using forceps.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: 16877041
• Report Number: 2024168-2023-04765
• Device Sequence Number: 7261674
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: 08717648211799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 02/29/2024
• Device Model Number: S-60-040-120-P6
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 2031861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown