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

Catalog Number SE-05-150-120-6F

Device Problems Material Separation (1562); Difficult or Delayed Activation (2577); Defective Device (2588); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2019

Event Type  Injury  

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.

Event Description

It was reported that the procedure was performed to treat a heavily calcified lesion in the popliteal artery.A 5x150mm supera self-expanding stent system (sess) was being deployed; however, the device locked and it was noticed that the tip was trapped in calcium.While trying to progress, the tip separated from sess, but blood continued to flow through the tip hole and the doctor chose not to intervene.There was some resistance at the beginning of stent release surpassing the distal popliteal artery with shortening of the stent cells and during stent retreat there was disconnection of the sds tip at the origin of the anterior tibial.The physician chose to perform control angiography with good patency of the popliteal artery (good runoff), and pervious anterior tibial artery despite containing the loosened tip.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 incidents.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the reported deployment issues were the result of anatomical challenges.It is possible that the distal sheath of the delivery system was entrapped or bent within the heavily calcified vessel such that the ratchet was unable to engage the stent properly resulting in deployment failure and difficulty advancing the thumbslide.Additionally, it is possible that the stent shortening, and tip detachment were the result of the difficulties positioning the device in the challenging anatomy during deployment.Forward motion on the delivery system during stent deployment would result in shortening of the stent and possibly entrapment of the tip causing separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.E1: first name, last name.

Event Description

Additional information: it was reported that the 5mm vessel was pre-dilated with an unspecified 6mm balloon at nominal pressure for two minutes.There was some resistance at the beginning of stent release with the thumb slide.The sess was removed under fluoroscopy.No additional information was provided.

• Brand Name: SUPERA PERIPHERAL 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: 9633121
• MDR Text Key: 176463783
• Report Number: 2024168-2020-00915
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: SE-05-150-120-6F
• Device Lot Number: 8041761
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR