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

Model Number	S-55-080-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 the highly calcified lesion in the mid superficial femoral artery.The vessel diameter was 5.5 mm and the vessel was prepped with a 5.5 mm armada balloon.A 6fr 45 cm sheath was used.The supera self expanding stent (ses) was deployed and when taking out the delivery catheter, the stent was still attached and came out of the patient with the catheter.There were no issues reported with the deployment mechanism.A new supera ses was deployed without issue.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported difficulties were unable to be confirmed as the stent was not returned with the delivery system.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 similar incidents.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the thumbslide was not retracted and the system lock was not locked prior to removal as instructed in the instruction for use resulting in the tip catching on the stent and pulling it out during removal; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 10218504
• Report Number: 2024168-2020-05456
• Device Sequence Number: 14054480
• Product Code: NIP
• UDI-Device Identifier: 08717648226106
• UDI-Public: 08717648226106
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 08/31/2021
• Device Model Number: S-55-080-120-P6
• Device Catalogue Number: S-55-080-120-P6
• Device Lot Number: 9092461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: 6FR 45 CM SHEATH