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

Catalog Number 42065200-120

Device Problems Entrapment of Device (1212); Material Separation (1562); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.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 superficial femoral artery.The 6.5mm vessel was pre-dilated with an unspecified 7mm balloon to around 8-10 atmospheres.A 6.5x200mm supera self-expanding stent system (sess) was deployed close to the introducer sheath and the last 1cm of the stent was accidently deployed in the sheath.The last lever was open and the stent fully released from the sess and deployed successfully.An attempt to fully retracted the thumbslide to the start position and lock both the system and deployment levers prior to removal was made; however, resistance with the thumbslide was felt and the nose cone separated immediately after from the delivery system.The sess was removed under fluoroscopy.The patient was sent to surgery and the tip cone and part of the shaft were removed via a cutdown.There was a clinically significant delay.The patient was released the next day with a good outcome.No additional information was provided.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported deployment difficulty, resistance with the thumbslide and entrapment were unable to be confirmed as it was based on circumstances of the procedure.The tip detachment was confirmed.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 similar complaints reported from this lot.The investigation determined that the reported difficulties and subsequent surgical procedure were related to case circumstances.Based on the reported information, it appears that inadequate distance between the introducer sheath and stent during deployment caused the stent to partially deploy within the sheath.Additionally, when attempting to fully retracted the thumbslide to the start position and lock both the system and deployment levers prior to removal, the tip separated likely due to reduced clearance for the tip to retract into the introducer sheath with the stent partially deployed in it.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Additional information: the nosecone was stuck in the sheath and in the stent; therefore, during the cutdown a part of the stent and sheath were removed with the nosecone.No additional information was 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: 11777936
• MDR Text Key: 249093739
• Report Number: 2024168-2021-03804
• 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: 06/15/2021

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: 07/31/2021
• Device Catalogue Number: 42065200-120
• Device Lot Number: 9080861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 05/22/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: 0.018; SHEATH: 6F X 11CM; GUIDE WIRE: 0.018; SHEATH: 6F X 11CM
• Patient Outcome(s): Hospitalization; Required Intervention