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 Codes	Material Separation (1562); Difficult or Delayed Activation (2577); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the right common femoral artery.The supera stent delivery system was advanced to the target lesion, and an attempt was made to deploy stent in the right common femoral artery; however, the stent would not release.The physician finally was able to get the stent to release; however, the proximal end twisted about 180 degrees.Two non-abbott stents were then deployed, with one of the stents implanted overlapping the supera, to fully expand the stent at the location it was twisted.During removal of the delivery system, the physician was aggressive and the delivery catheter separated.All portions of the device were able to be removed without any additional intervention.There was no adverse patient effect and no clinically significant delay 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 revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents reported from this lot.The investigation determined the reported difficulties resulting in unexpected medical intervention were likely due to circumstances of the procedure.It is likely that the distal sheath of the delivery system was entrapped or bent in the anatomy (possibly at the aortic bifurcation) such that the ratchet was unable to properly engage the stent resulting in difficulty deploying.Additionally, the material deformation of the stent was likely the result of the delivery system being twisted and torqued to fully release the stent.Reportedly, the shaft separation occurred due to aggressive removal of the delivery system.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents reported from this lot.The investigation determined the reported difficulties resulting in unexpected medical intervention were likely due to circumstances of the procedure.It is likely that the distal sheath of the delivery system was entrapped or bent in the anatomy (possibly at the aortic bifurcation) such that the ratchet was unable to properly engage the stent resulting in difficulty deploying.Additionally, the material deformation of the stent was likely the result of the delivery system being twisted and torqued to fully release the stent.Reportedly, the shaft separation occurred due to aggressive removal of the delivery system.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the right common femoral artery.The supera stent delivery system was advanced to the target lesion, and an attempt was made to deploy stent in the right common femoral artery; however, the stent would not release.The physician finally was able to get the stent to release; however, the proximal end twisted about 180 degrees.Two non-abbott stents were then deployed, with one of the stents implanted overlapping the supera, to fully expand the stent at the location it was twisted.During removal of the delivery system, the physician was aggressive and the delivery catheter separated.All portions of the device were able to be removed without any additional intervention.There was no adverse patient effect and no clinically significant delay in the procedure.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: 13211805
• Report Number: 2024168-2022-00324
• Device Sequence Number: 1533964
• Product Code: NIP
• UDI-Device Identifier: 08717648211805
• UDI-Public: 08717648211805
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: S-60-060-120-P6
• Device Catalogue Number: S-60-060-120-P6
• Device Lot Number: 1033061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown