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

Model Number S-60-120-120-P6

Device Problems Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Evaluation has not yet started.A follow up report will be submitted with all additional relevant information.The 6x150mm supera sess is 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 against resistance to the lesion and implanted.Due to the heavy calcification, the physician intentionally deployed the stent in a slightly compressed, controlled manner.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 was able to be pushed, but the stent would not further deploy.The partially deployed stent was simply removed from the guiding catheter.A 6x120mm supera sess was advanced to the lesion, also with resistance from the anatomy.After approximately 4cm of the stent was deployed, the thumb slide was able to be pushed, but 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

Visual and functional analysis was performed on the returned device.The reported activation failure and resistance with the thumbslide was not confirmed during functional testing.The reported difficult to advance with the anatomy was not tested as it was related to anatomical conditions.During functional testing, the reported deployment difficulty was not confirmed.The thumbslide was advanced and retracted and the slider operated properly, no resistance was felt, the rest of the stent was deployed with no anomalies and no resistance.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.The first 6x150mm supera stent system mentioned in b5 is filed under a separate medwatch report numberna.

Event Description

Subsequent to the initial medwatch report, the following information was provided: the first 6x150mm supera stent initially partially deployed, then with manipulated, the stent was fully deployed at the intended site.There was no additional information provided.

• 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: 10907606
• MDR Text Key: 219563828
• Report Number: 2024168-2020-09947
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• 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,distri
• 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: 11/26/2020
• 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-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 9040961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1