MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1012015-150

Device Problems Stretched (1601); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

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

Event Date 12/18/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the chronic totally occluded superficial femoral artery (sfa).Balloon dilatation was performed and a 4.5x150 mm supera self expanding stent (ses) was implanted.Next, the 6x150 mm absolute pro ses was attempted to be deployed but there was severe resistance when scrolling the thumbwheel.The stent was ultimately deployed in the target lesion and was elongated for most of the length of the stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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.

Manufacturer Narrative

The device was returned for analysis.The reported resistance/sticking of the thumbwheel was able to be confirmed.The reported difficult or delayed activation and the reported stretched stent was unable to be replicated in a testing environment due to the condition of the returned device (stent previously deployed and not returned).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 did not indicate a lot specific quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interactions with the totally occluded anatomy and/or inadvertent mishandling resulted in the noted device damages (kinked inner member, multiple distal sheath kinks/chatter marks) thus preventing the shaft lumens from moving freely, resulting in the reported resistance with the thumbwheel and the reported difficulty deploying the stent.The reported difficulties deploying the stent likely resulted in the reported stretched stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.A cine was received and reviewed by an abbott vascular clinical specialist.In summary, the media attached to this complaint does reflect multiple stents placed in the popliteal and superficial femoral artery (sfa).It is unknown the type of balloons used in this procedure pre and post stent deployment, the size, the inflation pressure, inflation times, and inflation frequency due to the information provided in this report.We do not know if the stent delivery systems were prepped and handled per the instructions for use.The media does reflect a stent in the popliteal and part of the distal superficial femoral artery (sfa) is deployed first.Afterwards another stent is deployed overlapping this stent in the distal sfa only, where it looks like this stent is elongated.Furthermore, two more stents are placed in the mid sfa and proximal sfa all overlapping the edge of each previous stent without issue.With the information provided per report and media, i cannot conclude a probable cause.

• Brand Name: ABSOLUTE PRO LL 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: 16125781
• MDR Text Key: 306981849
• Report Number: 2024168-2023-00306
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P110028
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• 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: 1012015-150
• Device Lot Number: 0012161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2020
• 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: 4.5X150 MM SUPERA; COMMAND 18 ST