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

Model Number	S-65-040-120-P6
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was report that the procedure was performed to treat a moderately calcified, non-tortuous de novo lesion in the right common femoral artery that was 90% stenosed.Vessel diameter was 7.0mm, lesion length was 30mm.Using contralateral femoral approach, pre-dilatation was performed with a 5.0x40mm non-abbott balloon and a 6.5x40mm non-abbott balloon (12atm 60 seconds 2 times / 16atm 120 seconds 1 time).The 6.5x40mm supera self-expanding stent system was advanced using a 28cm sheath and a non-abbott guidewire.During deployment, the deployment lock was unlocked and the thumbslide was advanced to deploy the stent, however, the stent did not release.The thumbslide was pulled back and advanced multiple times without success.The shaft was then pulled back for removal which caused the stent to release in the target lesion.There was a slight elongation of the stent which was recovered by post dilatation.Per the physician's opinion, there was no issue deploying the middle section, therefore the cause of deployment failure was unknown.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 one other incident.However, this is not a lot specific product quality issue.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the lesion was narrowed/constricted even after pre-dilatation was performed causing the elongation; or perhaps the delivery system was inadvertently pulled back during deployment causing the stent to elongate.However, this could not be confirmed.The post dilation of the stent to recover was 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 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: 11623855
• Report Number: 2024168-2021-02805
• Device Sequence Number: 17064643
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 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?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/12/2021
• 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: PARENT 60 28CM SHEATH; VASSALLO NS3 GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention