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

Catalog Number 42065040-120

Device Problems Entrapment of Device (1212); Product Quality Problem (1506)

Patient Problems Ischemia (1942); Thrombosis/Thrombus (4440)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

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 performed to treat a lesion in the superficial femoral artery.The target lesion was treated with atherectomy.The supera stent delivery system was advanced to the target lesion, using a.014 non-abbott filter device wire and a 7french sheath.The supera stent was deployed without issue; however, it was noted that the proximal edge of the supera stent was deformed upon deployment.No difficulty was noted during removal of the stent delivery system.A 4french catheter was then advanced; however, the catheter was unable to advance any further than the proximal end of the supera stent.It was suspected that the guide wire was catching of the deformed proximal edge, resulting in the 4french catheter being unable to advance any further than the proximal end of the supera stent.Additional catheters were advanced, but all were unable to cross the stent.As the non-abbott filter was still on the wire, the guide wire was not able to be pulled back for removal.A.014 balloon dilatation catheter balloon was inflated at the stent, and a long 5french sheath was advanced behind the stent and to the filter, for retrieval of the filter.There was thrombus formation and slow flow noted, likely related to the full filter that took longer to retrieve.The filter was able to be retrieved.Heparin infusion and urokinase were administered as treatment.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported entrapment was not tested as the stent was not returned.The reported irregular appearance was not tested as the component was not returned.Additionally, it was noted that the outer sheath was bent.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 similar incidents reported from this lot.A cine review was conducted in order to get better visualization on the event.The video clip provided is a poor-quality clip (blurry/grainy).It is evident that the advanced catheter was not able to progress past the proximal tip of the stent.The reason for the inability to advance was not distinct.The additional image provided did show thrombus within the stent.The investigation determined that procedural circumstances are the likely contributor to the reported difficulties.It is likely that the supera stent was deformed on the proximal end during deployment resulting in difficulties for the associated devices.This resulted in the entrapped stent and likely caused the outer sheath to bend; thus, likely due to procedural circumstances.It is inconclusive as to what caused the stent to distort as it was not returned for analysis.The administered medication is due to the reported reduced blood flow and noted thrombus contributed to challenging procedural circumstances.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: 11995688
• MDR Text Key: 256173174
• Report Number: 2024168-2021-04953
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 42065040-120
• Device Lot Number: 0072361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPIDER FILTER WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 80