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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM
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ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 1011922-060
Device Problems Break (1069); Premature Activation (1484); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat the right external iliac artery with heavy calcification and mild tortuosity.There was a dissection in the vessel.The 7.0x60 mm absolute pro self-expanding stent system (sess) was flushed and the stylet was removed and the delivery system was moved over the non-abbott guide wire through the 6fr sheath into the vessel.Before reaching the target lesion it was noted that the handle of the device had broken apart and the proximal part of the catheter was not fixed in the handle anymore.Therefore the device was removed.The guide wire was clamped [stuck] somewhere in the guide wire lumen so the guide wire was inadvertently removed as well so a new way had to be found to the dissection.A non-abbott stent was used to complete the procedure.There were no reported adverse patient effects.Although there was a delay in the procedure, there was no effect to the patient due to the extra time.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported break-handle and the reported difficult to remove were unable to be confirmed.The reported premature activation was able 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.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 onto the guide wire inadvertent mishandling resulted in the noted kinked sheath; thus resulting in guide wire resistance and the reported difficult to remove.An attempt to separate the device from the guide wire inadvertently resulted in a partial activation of the stent.The reported handle break was not confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
 
Event Description
It was reported that the procedure was to treat the right external iliac artery with heavy calcification and mild tortuosity.There was a dissection in the vessel.The 7.0x60 mm absolute pro self-expanding stent system (sess) was flushed and the stylet was removed and the delivery system was moved over the non-abbott guide wire through the 6fr sheath into the vessel.Before reaching the target lesion it was noted that the handle of the device had broken apart and the proximal part of the catheter was not fixed in the handle anymore.Therefore the device was removed.The guide wire was clamped [stuck] somewhere in the guide wire lumen so the guide wire was inadvertently removed as well so a new way had to be found to the dissection.A non-abbott stent was used to complete the procedure.There were no reported adverse patient effects.Although there was a delay in the procedure, there was no effect to the patient due to the extra time.Subsequent to the initially filed report the following information was provided: return device analysis noted that the stent of the absolute pro sess was partially deployed.Follow-up with the account stated that the physician thinks this occurred outside the anatomy during the attempts to remove the stuck guide wire; however, this was not confirmed.No additional information was provided.
 
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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
MDR Report Key12105011
MDR Text Key259656093
Report Number2024168-2021-05666
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
PMA/PMN Number
K072708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/16/2021
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 Date02/28/2023
Device Catalogue Number1011922-060
Device Lot Number0033061
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Initial Date Manufacturer Received 06/10/2021
Initial Date FDA Received07/01/2021
Supplement Dates Manufacturer Received08/03/2021
Supplement Dates FDA Received08/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
6FR SHEATH; TERUMO GLIDEWIRE STIFF 35; 6FR SHEATH; TERUMO GLIDEWIRE STIFF 35
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