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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM
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ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Model Number 1012534-100
Device Problems Break (1069); Mechanical Jam (2983); Activation Failure (3270)
Patient Problem Failure of Implant (1924)
Event Date 02/08/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that the procedure was to treat a left superficial femoral artery.Lesion was pre-dilated with a 5mm balloon.An absolute pro stent was advanced and deployment initiated.Some of the stent was already partially deployed when the ratchet became stuck on the deployment lever, so it was decided to remove the device completely.But when the catheter was pulled back, the stent further deployed a bit more (still partially remaining in the sheath).It was also noted that the stent implant had fractured (not in two pieces).The device was simply withdrawn.A 6x100 absolute pro was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
A visual and functional analysis was performed on the returned device.The reported deployment issue, resistance with the thumbwheel and broken stent were not confirmed as the stent was already fully 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 identified no indication of a lot specific product quality issue.The investigation was unable to determine a definitive cause for the difficulties.It may be possible that the distal shaft was bent or restricted in the anatomy (possibly at the aortic bifurcation) preventing the shaft lumens from moving freely and causing resistance with the thumbwheel; however, this could not be confirmed.The chatter marks noted throughout the shaft further indicate that the shaft was likely bent over an acute angle.The reported stent fracture was likely the result of retracting the stent system with the stent partially deployed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
 
Event Description
It was reported that the procedure was to treat a left superficial femoral artery.Lesion was pre-dilated with a 5mm balloon.An absolute pro stent was advanced and deployment initiated.Some of the stent was already partially deployed when the ratchet became stuck on the deployment lever, so it was decided to remove the device completely.But when the catheter was pulled back, the stent further deployed a bit more (still partially remaining in the sheath).It was also noted that the stent implant had fractured (not in two pieces).The device was simply withdrawn.A 6x100 absolute pro was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the previously filed mdr report, it was confirmed that the lesion location was to treat a right superficial femoral artery that was 50% stenosed and not the left superficial femoral artery as initially reported.No additional information was provided.
 
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Brand Name
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Type of Device
SELF EXPANDING PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11379756
MDR Text Key240034242
Report Number2024168-2021-01477
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08717648176012
UDI-Public08717648176012
Combination Product (y/n)N
PMA/PMN Number
P110028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Model Number1012534-100
Device Catalogue Number1012534-100
Device Lot Number9070961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Date Manufacturer Received03/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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