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

Model Number S-50-080-120-P6

Device Problems Improper or Incorrect Procedure or Method (2017); Activation Failure (3270); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.(b)(6).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 popliteal artery.A 6frx45cm sheath was advanced and the lesion was pre-dilated with a 4mm unspecified balloon dilatation catheter and atherectomy.A 5.0x80mm supera self-expanding stent system (sess) was advanced; however, half way through the stent deployment the stent jumped back towards the delivery system.The deployment lock was not unlocked and the thumb slide was not advanced to the most distal position on the handle.It was believed that if the deployment of the stent continued, the lesion would have been missed; therefore, the stent was removed with the sess under fluoroscopy.The procedure was successfully completed with a new unspecified device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported difficulties were unable to be 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 other similar incidents.It was reported that the procedure was performed to treat a lesion in the popliteal artery.A 6frx45cm sheath was advanced and the lesion was pre-dilated with a 4mm unspecified balloon dilatation catheter and atherectomy.The supera instruction for use (ifu) states that the recommended inflated balloon diameter for a 5.0 mm stent is greater than 5.0 mm.Using a 4.0 mm balloon to pre-dilate the vessel likely caused the reported difficulties.The investigation determined that the reported difficulties were user related.It is likely that inadequate preparation of the vessel contributed to the difficulties.It is likely that the stent diameter was slightly larger than the vessel diameter resulting in the stent elongating back towards the delivery system.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9216577
• MDR Text Key: 174738061
• Report Number: 2024168-2019-12807
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: 08717648211751
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: S-50-080-120-P6
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 8100261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6FR 45CM
• Patient Age: 68 YR
• Patient Weight: 107