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

Catalog Number 42055120-120

Device Problems Break (1069); Difficult or Delayed Activation (2577); Defective Device (2588); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 12/29/2022

Event Type  malfunction  

Manufacturer Narrative

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 to treat a lesion in an superficial femoral artery (sfa) with 85% stenosis, moderate calcification and mild tortuosity.Vessel diameter was 5mm and was prepared using a 5.0x150mm balloon at 16 atmospheres (atms) for 2 minutes.Atherectomy was not used.The 5.5x120mm supera self-expanding stent system (sess) deployment lock was unlocked and the thumb slide advanced to the most distal position on the handle and was delivered to the lesion but the stent became shorter than nominal of about 10%.The catheter was noted to be difficult to pull back and there was physical resistance with the thumbwheel and thumbslide.When the catheter was removed under fluoroscopy, it was observed that the catheter tip was broken but not totally separated.There was no adverse patient effect 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 deformation due to compressive stress tip was able to be confirmed.The reported difficult or delayed activation was unable to be replicated in a testing environment due to the condition of the returned device.The reported defective device stent shortened was unable to be confirmed as the stent was not returned.The reported physical resistance / sticking thumbslide was unable to be confirmed.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.It is possible that the distal sheath of the delivery system was entrapped or bent in the moderately calcified, mildly torturous and 85% stenosed anatomy such that the ratchet was unable to properly/fully engage the stent resulting in physical resistance thumbslide; however, this could not be confirmed.During stent deployment interaction with the moderately calcified, mildly torturous and 85% stenosed anatomy and/or the delivery system was slightly pushed distally as the stent was being deployed resulting in the reported shortened stent and the reported difficult or delayed activation; however, this could not be confirmed.The investigation determined a conclusive cause for the reported physical resistance thumbslide, the reported shortened stent and the reported difficult or delayed activation difficulties cannot be determined.Manipulation/interaction of the device likely resulted in the reported tip kink/noted smashed tip and the noted folded sheath.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 1069 was removed and rdc 2889 - tip was added.

Event Description

It was reported that the procedure was to treat a lesion in an superficial femoral artery (sfa) with 85% stenosis, moderate calcification and mild tortuosity.Vessel diameter was 5mm and was prepared using a 5.0x150mm balloon at 16 atmospheres (atms) for 2 minutes.Atherectomy was not used.The 5.5x120mm supera self-expanding stent system (sess) deployment lock was unlocked and the thumb slide advanced to the most distal position on the handle and was delivered to the lesion but the stent became shorter than nominal of about 10%.The catheter was noted to be difficult to pull back and there was physical resistance with the thumbwheel and thumbslide.When the catheter was removed under fluoroscopy, it was observed that the catheter tip was broken but not totally separated.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified that there was no break and or separation noted to the distal tip.It was confirmed by the account that the tip was kinked.No additional information was provided.

• 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: 16195080
• MDR Text Key: 308445438
• Report Number: 2024168-2023-00648
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 42055120-120
• Device Lot Number: 1012561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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
• Treatment: .018 GUIDE WIRE; 6FRENCH 5CM SHEATH