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

Catalog Number 42055040-120

Device Problems Premature Activation (1484); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 75% stenosed lesion in the distal superficial femoral artery (dsfa).After device preparation, the 5.5x40mmx120cm supera peripheral self-expanding stent system (sess) was advanced with no noted resistance; however, the stent prematurely deployed in the anatomy before the stent deployment lock was opened.The system lock was brought back to its original position and the stent delivery system removed; however, it was noted that the nose cone separated and was inside the vessel.Removal of the separated nose cone was difficult, but was eventually removed with a snare device.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: the stent prematurely deployed in the target lesion before the stent deployment lock was opened.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported tip material separation was able to be confirmed.The reported premature activation was unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.Additionally, it was noted that the inner member and tip jacket material had separations.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 incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.In conclusion: the media (video and image) does confirm that there is a malfunction in the device as the self expanding stent system (sess) tip of the catheter is separated in the image and visualized being removed with the snare in the video.We are unaware what pre-treatment devices were applied to the target complex lesion prior to the deployment of the supera sess.This is a concern since if the complex lesion was not pre-treated appropriately prior to the introduction of the sess, the characteristics of the lesion indicated in the report may or may not influence device performance.In addition, the report states that the device was prepared without an issue, we unfortunately cannot assume that this was done per ifu, as well as the device handled per the ifu prior to insertion into the body.There is no probable cause for the event.It is possible that prior to unlocking the deployment lock interactions with the moderately calcified, mildly tortuous and 75% stenosed anatomy and/or the delivery system was inadvertently pulled back slightly resulting in inadvertent full deployment of the stent; however, this could not be confirmed.The investigation determined a conclusive cause for the reported premature activation/deployment cannot be determined.During removal interaction with other devices and/or the moderately calcified, mildly tortuous and 75% stenosed anatomy likely resulted in the reported tip material separation and noted inner member and tip jacket material separations; thus resulting in the reported difficult to remove.The treatment appears to be related to the operational context of the procedure as the separated nose cone was eventually removed with a snare device.There is no indication of a product quality issue with respect to manufacture, design or labeling.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16717628
• MDR Text Key: 313105783
• Report Number: 2024168-2023-03707
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 42055040-120
• Device Lot Number: 201186R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention