MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA 6F; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number S-55-120-120-P6

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.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 chronic totally occluded and heavily calcified de novo lesion in the mid to proximal right superficial femoral artery (sfa).The lesion was pre-dilated with an unspecified 6.0 high-pressure balloon at 12 atmospheres for 60 seconds and atherectomy.A 5.5x120mm supera self-expanding stent system (sess) was advanced and deployed.The deployment lock was unlocked and the thumb slide was advanced completely and the use of fluorography was stopped and the sess was removed.No resistance was felt during removal; however, re-flow blood was observed from the y-connector when the sess crossed through it.It was then noted that the stent was stuck in the y-connector.The stent was noted to be stretched and dislodged from the sess.The stent was able to be pulled out of the y-connector smoothly.The procedure was successfully completed with the deployment of a 5.0x120mm supera stent in the mid right sfa and a new 5.5x120mm supera stent overlapped at the proximal.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deployment issue and dislodgement was not confirmed as the stent had already been fully deployed and was not returned.In this case the difficulty to remove was not confirmed.The noted bends on the sheath were likely caused by case circumstances.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 revealed no other similar complaints.It should be noted that the supera instruction for use states: under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.Failing to use fluoroscopy during removal does not appear to have contributed to the initial deployment difficulty.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal sheath of the delivery system was entrapped or bent within the anatomy such that the ratchet was unable to properly engage stent during the final deployment stroke; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA 6F
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10374876
• MDR Text Key: 202049003
• Report Number: 2024168-2020-06581
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226144
• UDI-Public: 08717648226144
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: S-55-120-120-P6
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 8091961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: PARENT 28CM