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

Model Number S-60-150-120-P6

Device Problems Difficult or Delayed Activation (2577); Difficult to Advance (2920); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

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.The additional two devices referenced are filed under a separate medwatch report number.

Event Description

It was reported that a contralateral approach was taken from the left circumflex artery (cfa) to treat a heavily calcified, mildly tortuous, 100% stenosed, de novo, right superficial femoral artery (sfa).After lesion preparation, a 6x150mm supera peripheral self-expanding stent system (sess) was advanced to the lesion against resistance from the calcified lesion.After stent deployment was initiated, and before the stent was fully deployed, the thumb slide continued to spin.The partially deployed stent was manipulated and deployed at the intended site; however, it was intentionally deployed in a slightly compressed, controlled manner, due to the lesion calcification.A second 6x150mm supera sess was advanced with resistance from the highly calcified anatomy.After approximately 2cm of the stent was deployed, the thumb slide continued to spin, and the stent would not further deploy.The partially deployed stent was simply removed from the guiding catheter.A 6x120mm supera ses was advanced to the lesion, also with resistance from the anatomy.After approximately 4cm of the stent was deployed the thumb slide continued to spin, and the stent would not further deploy.The partially deployed stent was simply removed from the guiding catheter.There was no adverse patient effect and no clinically significant delay in the procedure.Two non-abbott stents were used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 no other similar complaints reported from this lot.The investigation determined that the reported difficulties were related to circumstances of the procedure.It is likely that anatomical conditions contributed to the reported difficulty advancing as the anatomy was described as highly calcified.Additionally, it is likely that the distal sheath of the delivery system was bent or entrapped in the challenging anatomy preventing the ratchet from engaging the stent properly resulting in difficulty advancing the thumbslide and partial deployment.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: 11092182
• MDR Text Key: 224858706
• Report Number: 2024168-2020-11004
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 9040261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1