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

Catalog Number 42060150-120

Device Problems Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous, total occlusion of the distal and proximal superior femoral artery (sfa) with a need for sub-intimal access.After pre-dilatation of the vessel, a 5.5x200mm supera peripheral stent (ses) was implanted at the lesion and angiographic images showed great results.A 6x150mm supera ses was then advanced to the lesion; however; the stent was not visible.The procedure was continued and the stent was implanted, over the previously implanted 5.5x200mm supera, instead of covering the rest of the lesion; therefore; a 6x80mm ses was implanted to cover the rest of the lesion and successfully complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficulty visualizing the stent could not be confirmed as the stent implanted and was not returned.The supera instruction for use, states: confirm under fluoroscopy that the entire supera stent has fully emerged form the outer sheath and is released.In this case, it could not be determined if any deviation to the ifu contributed to the event.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 incidents and/or complaints.Potential causes for difficulty positioning the supera due to visibility issues include, but are not limited to, angle of the imaging device, materials, location in anatomy and/or anatomical conditions.In this case, the stent was not returned for evaluation and a cause for the difficulty visualizing the stent could not be determined.It may be possible that anatomical conditions contributed to the difficulty; however, this could not be confirmed.Based on the information provided, a conclusive cause for the reported difficulties could not be determined.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
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11019921
• MDR Text Key: 225339082
• Report Number: 2024168-2020-10583
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 42060150-120
• Device Lot Number: 0021361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPERA 5.5X200