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

Model Number	S-55-060-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified right superior femoral artery (sfa) that is 100% stenosed.Pre-dilatation was performed with four non-abbott balloon catheters.A 5.0x60mm supera self-expanding stent system (sess) was advanced to a 6.0mm vessel with residual calcification, it was noted that the physician used the pull-through guide wire technique due to the heavily calcified lesion.Resistance was felt during removal of the sess with a non-abbott guide wire and the tip separated.An attempt to remove the separated tip with a snare and forceps was made; however, failed.A microcatheter was inserted and the separated tip remaining on the guide wire was pushed retrogradely into the sheath and removed successfully.The sess was removed under fluoroscopy.It was noted that the physician intentionally created compression at the implant site of the supera stent, therefore causing the stent to be partially compressed.There was no adverse patient sequela and no significant clinically delay.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The tip separation was confirmed.The difficult to remove could not be tested due to the condition of the returned device.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 related incidents.The investigation determined the cause of the difficulty removing, and separation were due to case circumstances.The additional therapy to snare and removal of the foreign body (separated portion of the tip), bend and deformation, were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10515399
• Report Number: 2024168-2020-07549
• Device Sequence Number: 11729733
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 10/31/2020
• Device Model Number: S-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 8113061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VASSALLO NS3 GUIDE WIRE; VASSALLO NS3 GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention