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

Model Number	S-50-100-120-P6
Medical Device Problem Codes	Stretched (1601); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 from this lot.It should be noted that the supera instruction for use, states: "under fluoroscopy, continuously and slowly retract and advance the thumb slide multiple times.In this case, it is likely that deploying the stent too quickly and retracting the delivery system during deployment caused the stent to elongate and come out with the device as reported the investigation determined that the reported difficulties appear to be use related.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the procedure was performed to treat a right superficial femoral artery.The vessel diameter was 5 mm.The lesion was ballooned and a 5.0x100mmx120cm supera self-expanding stent system (sess) was advanced to the lesion.Stent deployment was initiated; however, the stent did not fully deploy, the proximal end of the stent stayed in the device.The user inadvertently forgot to unlock the distal lever when releasing the stent.When retracting the sess, the stent elongated and completely came out with the device.A new supera was used without issue to complete the procedure.There were no adverse patient effects and no clinically significant delay during the procedure.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: 11828604
• Report Number: 2024168-2021-04094
• Device Sequence Number: 4179539
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: 08717648211768
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 06/30/2022
• Device Model Number: S-50-100-120-P6
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 0072161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 43