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

Catalog Number 42075060-120

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Migration (4003)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - incorrect removal.

Event Description

It was reported that the procedure was to treat a lesion in the left iliac artery with moderate calcification and mild tortuosity.The vessel diameter was 7.5mm and pre-dilatation was performed with a 7.0mm non-abbott balloon inflated higher than nominal pressure for 3 minutes.Atherectomy was not used.The 7.5x60mm supera self-expanding stent system (sess) was advanced without resistance but the stent was deployed inadvertently too close to the entrance of the introducer.However, the stent was fully deployed evenly across the entire lesion.Upon removal not done under fluoroscopy, the distal catheter tip must have gotten stuck with the implanted stent struts as the tip was missing.The introducer sheath was then retrieved but the stent came out too attached to the catheter tip.The introducer must have also been stuck in the stent struts.The procedure ended without putting another stent.There was no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported stent migration was unable to be replicated in a testing environment as it was based on operational circumstances.The reported device damaged by another device was unable to be replicated in a testing environment due to the condition of the returned device.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: based on the single radiographic image provided it does appear that the supera stent was deployed in such a manner as to be partially deployed within the introducer sheath used for vascular access.It is unknown what length of stent was deployed within the introducer sheath, but it appears to have been enough such that the stent was held in place by the outward expansion (radial force) of the nitinol stent material while the physician removed the introducer sheath.Based on the radiographic image provided the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the supera stent was inadvertently deployed partially within the introducer sheath resulting in the reported device damaged by another device.Manipulation of the compromised device resulted in the reported stent migration and ultimately resulted in the reported tip separation/noted tip jacket and inner member separations.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2017 removed.

• 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: 17599611
• MDR Text Key: 321723527
• Report Number: 2024168-2023-09155
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42075060-120
• Device Lot Number: 3041861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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