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

Catalog Number	S-65-060-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the non-tortuous, heavily calcified left superficial femoral artery (sfa).Unspecified balloon inflation was performed, and a command.014 guide wire was used along with a non-abbott sheath without any issues.Balloon inflation was performed again and a 6.5x60mm supera self-expanding stent was advanced with resistance due to the anatomy.The stent was deployed, but when the device was pulled back, resistance with the anatomy was felt and the nose cone separated from the delivery system.Balloon inflation was performed once more, and another unspecified supera stent was implanted in the lesion without issues.A snare device was used to remove the nose cone, and the first supera stent remained implanted in the lesion.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual analysis was performed on the returned device.Only the catheter tip and portion of the inner member were returned, confirming the tip detachment.The difficulty advancing and removing was not tested as the delivery system was not returned.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 complaints.The investigation was unable to determine that the reported difficulties appear to be due anatomical conditions.The resistance advancing and difficulty removing resulting in tip detachment were likely due to interaction with the heavily calcified lesion.It is likely that the tip of the supera was bent or entrapped within the vessel calcification and during withdrawal, the tip separated.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: 9129806
• Report Number: 2024168-2019-12145
• Device Sequence Number: 2312707
• Product Code: NIP
• UDI-Device Identifier: 08717648226243
• UDI-Public: 08717648226243
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 11/30/2020
• Device Catalogue Number: S-65-060-120-P6
• Device Lot Number: 8121761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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: COMMAND .014 GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 73