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

Catalog Number S-60-150-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in patient.The delivery system is not returning.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 90% stenosed lesion in the distal superficial femoral artery.The lesion was pre-dilatated with a 6x200mm balloon catheter at 8 atmospheres and atherectomy was performed.A 6fr sheath was used.A 6.0x150mm supera stent was being deployed; however, the stent migrated before being fully deployed.During removal, the thumb slide was not fully retracted to the start position and both the system and deployment levers were not locked prior to removal without the use of fluoroscopy.The self-expanding stent system (sess) became caught with the guiding catheter and the nose cone detached.A snare was used to remove the separated nose cone.The procedure was successfully completed with the deployment of a second unspecified stent.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.The supera instruction for use (ifu) instructs: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.Under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.In this case, failing to retract and lock the thumbslide into place and remove the device under fluoroscopy appears to be the likely cause for the reported difficulty removing and tip detachment.Based on the information provided, the reported difficulties appear to be user/case related.Failing to retract and lock the thumbslide into place and remove the device under fluoroscopy appears to be the likely cause for the reported difficulties.The additional treatment to remove the separated tip was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Additional information: it was confirmed that the supera stent was deployed partially in the target lesion.

• 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: 9136303
• MDR Text Key: 161577651
• Report Number: 2024168-2019-12223
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-60-150-120-P6
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6FR DESTINATION 45CM.
• Patient Outcome(s): Required Intervention
• Patient Weight: 120