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

Model Number	S-60-100-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.(b)(4).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 a left superficial femoral (sfa) to popliteal artery.A non-abbott atherectomy device was used.Then a 6mm non-abbott drug-eluting balloon was advanced and dissected the distal sfa and popliteal.About six non-abbott stents were deployed at the lesion to treat the dissection, but were unsuccessful as the artery remained dissected.Then a non-abbott balloon was advanced but failed to cross.An unspecified armada balloon was used and successfully dilated the lesion.The dissection had resolved.A 6.0x100 supera self expanding stent was then advanced to the lesion, with some resistance met due to the anatomy, but reached the dissection.The physician believed he had deployed the stent without issue, but did not realize that he did not unlock the deployment lock fully to the most distal position on the handle.Then when pulling out the delivery system through the introducer sheath, it was noted that the stent was only partially deployed as the entire stent was pulled back into the sheath.Resistance was met with the introducer sheath during removal.The introducer sheath and supera device were removed altogether as a single unit.Once outside of the anatomy, the physician then performed troubleshooting and was able to remove the entire stent out of the introducer sheath.Then it was noted that the catheter tip of the supera had separated within the stent implant.Nothing was left in the anatomy.A 5.0mm armada balloon was used to post-dilate the non-abbott stent and successfully complete the procedure.No additional intervention/procedure was performed.The patient is fine.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 deployment issue was not confirmed as the stent had already been fully deployed and was not returned.The tip detachment was confirmed.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 revealed no other complaints.It should be noted that the supera instruction for use (ifu) instructs: while maintaining increased magnification from step 3, rotate the deployment lock to the unlocked position.The investigation was unable to determine a cause for the reported difficulties.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: 9306448
• Report Number: 2024168-2019-13446
• Device Sequence Number: 14065578
• Product Code: NIP
• UDI-Device Identifier: 08717648211829
• UDI-Public: 08717648211829
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 02/03/2020

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: 07/31/2020
• Device Model Number: S-60-100-120-P6
• Device Catalogue Number: S-60-100-120-P6
• Device Lot Number: 8082161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 86