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

Catalog Number 42055060-080

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Foreign Body In Patient (2687)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 to treat a superficial femoral artery (sfa).The lesion was pre-dilated with a 5.5mm armada balloon at 18-20 atmospheres for approximately 2 minutes.Atherectomy was not performed.Following deployment of a 5mm supera, the thumbslide was locked and retrieval of the delivery system was attempted (without fluoroscopy) upon which it is assumed that the tip of the supera device got caught in the stent and moved the stent proximally towards the common femoral artery near the 6f sheath, which is not the target lesion and remains there.Then it was observed under fluoroscopy that the white tip of the supera device had broken off.The tip was then moved with a support catheter and embedded to a distal/collateral vessel and remains in patient.A subsequent supera stent was then placed in the sfa of the patient.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported tip detachment (foreign body) was confirmed.The migration was not tested as the stent was not returned and remains in the patient.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 complaints.The investigation could not determine the cause for the reported tip separation and migration which led to the additional therapy, and tip embedded in vessel.The returned device analysis noted that the handles system lock was in an unlocked position and the slider was at the distal end of the handle.It may be possible, the thumbslide was not retracted and the system lock was not locked prior to removal which resulted in the tip catching in the stent, however, this could not be confirmed.Additionally, it was reported that the delivery system was removed without the use of fluoroscopy contrary to the instructions for use (ifu).Use of fluoroscopy during the removal step may have prevented the tip detachment.The supera (ifu) instructs: ¿under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.¿ additionally, the same section 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.¿ it could not be determined if failing to lock the system lock or removal of the system without use of fluoroscopy caused or contributed to the difficulties.The additional hospitalization was likely related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 10752044
• MDR Text Key: 213627237
• Report Number: 2024168-2020-09009
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 42055060-080
• Device Lot Number: 0031061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.018" GUIDE WIRE; 6 FR SHEATH; 0.018" GUIDE WIRE; 6 FR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention