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

Model Number	S-55-040-120-P6
Medical Device Problem Codes	Stretched (1601); Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
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 similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It is possible that the limited clearance within the anatomy (heavily calcified) caused the stent to elongate and changed its shape as such this ¿tight part¿ caused difficulties for the non-abbott balloon during advancement; however, this cannot be confirmed.The additional placement of another non-abbott balloon that was dilated at the distal part and proximal part of the supera stent to correct the elongated/tight stent was due to case circumstances.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 performed to treat a heavily calcified, mildly tortuous de novo left superficial femoral artery that was 50% stenosed.Vessel diameter was 4.5mm, lesion length was 250mm.Using a contralateral approach from the left common femoral artery, a non-abbott guidewire was placed then a 5.0x20mm non-abbott balloon was used to dilate a calcified nodule at 4atm several times, then a 5.0x100mm non-abbott balloon was used to dilate the entire lesion at 30atm.The 5.5x40 supera stent was implanted.The stent was tight at the calcified nodule.Part of the stent was elongated for a total length of 50mm.A 4.0x40mm non-abbott balloon was attempted to be delivered to a popliteal lesion but resistance was felt advancing through the implanted supera stent.The delivery was stopped, and it was then confirmed by fluorography that the supera stent had stretched for an approximate total length of 70mm.A non-abbott balloon was used to dilate the distal and proximal part of the supera stent, then the procedure was successfully completed.In the physician¿s opinion, it was possible that the balloon became caught with the tight part of the implanted supera stent.There was no adverse patient sequela reported.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
• MDR Report Key: 11610678
• Report Number: 2024168-2021-02697
• Device Sequence Number: 3898564
• Product Code: NIP
• UDI-Device Identifier: 08717648226069
• UDI-Public: 08717648226069
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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: 08/31/2021
• Device Model Number: S-55-040-120-P6
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 9091961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention