MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1011920-040

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa).Using the crossover approach, the 5.00x40mm absolute pro self-expanding stent system (sess) was advanced to the target lesion; however the sess was not able to be placed in the correct position and while pulling back the sess the stent cover partially removed and the stent partially deployed in the introducer sheath.The physician was able to pull the shaft and stent back into the sheath and remove the sess from the patient anatomy.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned for analysis.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 advance was unable to be replicated in a testing environment as it was based on operational circumstances.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.Reportedly, an 0.018 guide wire was used.It should be noted the absolute pro ll peripheral self-expanding stent system instructions for use (ifu) states: use a 0.035¿ (0.89 mm) diameter guide wire with the absolute pro.035 peripheral self-expanding stent system.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.The investigation determined the reported difficulties appear to be related to deviation of the ifu and subsequent circumstances of the procedure as it is likely that the use of the undersized 0.018 guidewire resulted in the noted device damages (multiple outer member kinks/cracks, sheath chatter marks on its entire length) resulting in the reported difficult to position.As the device was being pulled back the noted device damages ultimately resulted in the reported premature activation as the outer member binds on the inner member creating tension.Further interaction of devices and/or manipulation of the device resulted in the noted smashed tip/sheath and the noted sheath separations.There is no indication of a product quality issue with respect to manufacture, design or labeling.E1: address 1.H6: medical device problem code 3270 removed.

Event Description

Subsequent, to initial report being filed, it was reported that the stent became partially deployed outside the introducer; therefore it was no longer possible to position the stent at the lesion.The absolute pro was able to be removed together (sess and sheath) from the anatomy as a single unit.No additional information was provided.

Manufacturer Narrative

Revised narrative: the device was returned for analysis.The reported mechanical jam and the reported activation failure were unable to be replicated in a testing environment due to the condition of the returned device.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 interaction with the moderate to severe anatomy and/or inadvertent mishandling resulted in the noted device damages (multiple outer member kinks/cracks, sheath chatter marks on its entire length) thus preventing the shaft lumens from moving freely resulting in the reported thumbwheel difficulties and ultimately resulting in the reported difficulty deploying the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.B5: describe event or problem updated.H6: medical device problem codes 2920, 1484 and 2017 were removed.H6: investigation conclusions code 18 was removed.

Event Description

Subsequent to the previously filed report, the following information was received: the absolute pro was successfully advanced to the lesion on a 0.035 guide wire, but the stent could not be fully deployed because the thumbwheel stuck.The guide wire was then exchanged to an 0.018 to see if that would resolve the issue with the thumbwheel, but the result was the same.The undeployed portion of the stent remained stuck in the shaft [sheath].Everything was able to be removed as a single unit from the patient¿s anatomy.No additional information was provided.

• Brand Name: ABSOLUTE PRO .035 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: 17263235
• MDR Text Key: 318591778
• Report Number: 2024168-2023-07072
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K072708
• 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,Followup
• Report Date: 09/07/2023

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 Catalogue Number: 1011920-040
• Device Lot Number: 3031561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/15/2023; Not provided
• Supplement Dates FDA Received: 08/22/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• 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
• Treatment: GUIDE WIRE: TERUMO 0.018"; UNSPECIFIED 0.035" GUIDE WIRE