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

Model Number	S-45-100-120-P6
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Separation (1562); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
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.As there was no reported 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 the stent was inadvertently not fully deployed from the sheath; thus during pullback back into the introducer sheath interaction resulted in the reported difficult to remove and ultimately resulted in the reported break/nose cone fracture.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a distal superficial femoral to popliteal arteries.The lesion was being pre-dilatated with a 3.0 unspecified balloon which caused a dissection.Then it was decided to use a supera stent to treat the dissection.The supera stent was advanced to the target lesion without issue and was thought to have been fully deployed.There was no issue with the deployment mechanism.During pullback back into the introducer sheath, resistance was met and it was noted that the nose cone had fractured (remaining in one piece) inside the sheath.Then it was also noted that the supera stent had not deployed at the lesion location but rather only partially deployed still remaining on the delivery system.It was decided to pull out all devices altogether.Nothing was left in the patient anatomy.Dissection was treated via ballooning with no issues and continues to be monitored.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported activation/deployment failure and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.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.As there was no reported 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 the stent was inadvertently not fully deployed from the sheath resulting in the reported activation/deployment failure; thus during pullback back into the introducer sheath interaction resulted in the reported difficult to remove and ultimately resulted in the reported tip separation/noted tip jacket and inner member separations.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.D9, h3 - device status changed from not returned to returned.H6: code 1069 was removed.H6; type of investigation code 4114 was removed.
Event or Problem Description
It was reported that the procedure was to treat a distal superficial femoral to popliteal arteries.The lesion was being pre-dilatated with a 3.0 unspecified balloon which caused a dissection.Then it was decided to use a supera stent to treat the dissection.The supera stent was advanced to the target lesion without issue and was thought to have been fully deployed.There was no issue with the deployment mechanism.During pullback back into the introducer sheath, resistance was met and it was noted that the nose cone had fractured (remaining in one piece) inside the sheath.Then it was also noted that the supera stent had not deployed at the lesion location but rather only partially deployed still remaining on the delivery system.It was decided to pull out all devices altogether.Nothing was left in the patient anatomy.Dissection was treated via ballooning with no issues and continues to be monitored.There was no adverse patient sequela and no clinically significant delay.Subsequent to the initially filed mdr report, additional information was provided: when the supera device was removed altogether as one unit, once outside of the anatomy, the physician troubleshooted the device.However, while examining the device it was confirmed that the nosecone had completely separated in two pieces and not simply fractured as previously thought.The stent implant and nosecone were discarded.It was further confirmed that no portion of the device remained in the anatomy.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: 16081961
• Report Number: 2024168-2023-00003
• Device Sequence Number: 15048549
• Product Code: NIP
• UDI-Device Identifier: 08717648225987
• UDI-Public: 08717648225987
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: 04/30/2023
• Device Model Number: S-45-100-120-P6
• Device Catalogue Number: S-45-100-120-P6
• Device Lot Number: 1050661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/02/2023
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: 6F ANSEL SHEATH
• Patient Age: 70 YR
• Patient Sex: Female