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

Model Number	S-50-120-120-P6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure to treat a right superficial femoral artery.Pre-dilatation was performed via csi atherectomy first then balloon angioplasty with a 4x200mm armada 14 balloon.The supera stent was advanced to the lesion and the stent was fully deployed.It was then realized that the stent implant deployed partially in the introducer sheath and the vessel.During deployment, the supera stent partially deployed in the introducer sheath and became elongated in the process.It was noted that the physician deployed the supera incorrectly.The introducer sheath was far away to the proximal end of the stent during deployment.The 120 length stent turned into a 300 length stent because of the user error.The introducer sheath and stent were removed together as a unit and wire access remained.A new sheath was placed and balloon angioplasty was performed to successfully complete the procedure.There was a small dissection noted at the lesion at the end of the procedure.The dissection was treated via csi (orbital atherectomy device) and ballooning.The cause of the dissection remains unknown.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
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 incidents from this lot.Reportedly, the physician did not deploy the supera stent correctly as he was not trained/unaware.It should be noted that the supera peripheral stent system instructions for use states: the supera peripheral stent system should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device.The reported patient effect of dissection is listed in the supera peripheral stent system instructions for use as a potential adverse event.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that due to the physician not being trained to the product the stent was deployed incorrectly resulting in the reported activation/deployment failure and the reported material deformation.The treatments appears to be related to the operational context of the procedure as the introducer sheath and stent were removed together as a unit and wire access remained.A new sheath was placed and balloon angioplasty was performed to successfully complete the procedure.The reported difficulties possibly caused/contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14552857
• Report Number: 2024168-2022-05811
• Device Sequence Number: 20491387
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: 08717648211775
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 11/30/2022
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 0120861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown