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

Catalog Number 1012015-120

Device Problems Stretched (1601); Difficult or Delayed Activation (2577); Noise, Audible (3273); Physical Resistance/Sticking (4012)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported the procedure was to treat a partly subintimal chronic total occlusion in the mid superficial femoral artery (sfa).The 6.0x120mm absolute pro ll self expanding stent system (ses) was placed in the target lesion however the thumbwheel stopped turning after a few rotations and a crack was heard, the stent only deployed 5mm.The delivery system was retracted and the stent was deployed however it elongated and was partially deployed in healthy tissue.A supera stent was deployed in the target lesion inside the absolute pro stent to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.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

Corrections: b1 - adverse event/product problem added adverse event.B2 - outcomes attributed to ae updated from "na" to "required intervention".H6- health effect - impact code 2199 was removed and replaced with code 4641.H6- medical device problem code 2017 clarifier: failure to follow steps/instructions.The device was returned for analysis.The reported physical resistance, difficult/delayed activation, noise, and stretched were 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 did not indicate a lot specific quality issue.Reportedly, an.018 guide wire was used.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.It should be noted the absolute pro ll peripheral self-expanding stent system instructions for use (ifu) states: one 0.035" (0.89 mm) diameter guide wire.As the deviation of the ifu appears to have contributed to the reported difficulties the deviation of the ifu will be addressed in the account requested letter.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 deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that during advancement use of the undersized.018¿ guide wire in conjunction with interaction with the anatomy resulted in bending the device such that it prevented the shaft lumens from moving freely causing resistance; thus during stent deployment resulted in the reported thumbwheel ¿crack sound¿, the reported thumbwheel physical resistance and ultimately resulted in the reported stent deployment difficulties.Manipulation of the compromised device resulted in the noted wrinkled sheath likely contributing to the reported deployment difficulties.Interaction with the anatomy and/or other devices during retraction of the compromised device resulted in the reported stretched stent as it was inadvertently partially deployed in healthy tissue.As reported, a supera stent was deployed in the target lesion inside the absolute pro stent to complete the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported the procedure was to treat a partly subintimal chronic total occlusion in the mid superficial femoral artery (sfa).The 6.0x120mm absolute pro ll self expanding stent system (ses) was placed in the target lesion however the thumbwheel stopped turning after a few rotations and a crack was heard, the stent only deployed 5mm.The delivery system was retracted and the stent was deployed however it elongated and was partially deployed in healthy tissue.A supera stent was deployed in the target lesion inside the absolute pro stent to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Subsequent to the previously filed report, additional information was received that the wrong size guidewire was used with the absolute pro ll.A duplicate event for this device was filed under mdr 2024168-2024-02915-00 and 2024168-2024-02915-01.No additional information was provided.

• 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: 18825248
• MDR Text Key: 336788153
• Report Number: 2024168-2024-02675
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012015-120
• Device Lot Number: 3072561
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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
• Patient Outcome(s): Required Intervention