MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA 6F; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	S-65-040-120-P6
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned.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 performed to treat a 75% stenosed and heavily calcified lesion in the mid superficial femoral artery.A 6f sheath and a ht command 18 guide wire were advanced to the lesion.Following pre-dilatation, a 6.5x40mm supera self-expanding stent system was advanced and an attempt to deploy the stent was performed.The thumb slide was advanced; however, the last 1cm failed to deploy despite further thumb slide advancements.The deployment lock was released; however, the stent did not fully deploy.The delivery system was pulled slowly out of the anatomy under fluoroscopy and the stent completely deployed from the system.The implanted stent seemed to be elongated by 30% at the 1cm section that deployed with the removal of the delivery system.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported difficulties were unable to be confirmed as the stent was already fully deployed and not returned.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 indication of a lot specific product quality issue.The investigation determined that the reported difficulties were related to circumstances of the procedure.The partial deployment appears to be due to ratchet to sheath interaction.The noted break to the ratchet and punctures noted sporadically in the distal outer sheath indicate that the ratchet had punctured into the sheath during advancement preventing further stent deployment and causing the thumbslide to stop moving.It is likely that the distal outer sheath was kinked in the anatomy causing the ratchet to sheath interaction.The reported stent elongation likely occurred as the delivery system was pulled back with the stent partially deployed in the vessel.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
N/a.

• Brand Name: SUPERA 6F
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9837791
• Report Number: 2024168-2020-02502
• Device Sequence Number: 1766995
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: 08717648226229
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 05/31/2021
• Device Model Number: S-65-040-120-P6
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 9061861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/20/2020
• 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: GUIDE WIRE: HT COMMAND 18; SHEATH: 6FX45CM DESTINATION