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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 1011921-060
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/12/2023
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
 
Event Description
It was reported that the 6.0x60mm absolute pro self-expanding stent system failed to cross as it met interaction with a previously implanted stent.It was noted that the delivery system was loose [break].Another same size absolute pro was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.The reported stent break was unable to be confirmed however there was a noted cracked handle.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 similar 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 interaction with the previously implanted stent resulted in the reported failure to advance.Manipulation of the device resulted in the noted device damages (wrinkled/bunched distal sheath) and ultimately resulted in the reported/noted cracked handle likely contributing to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the 6.0x60mm absolute pro self-expanding stent system failed to cross as it met interaction with a previously implanted stent.It was noted that the delivery system was loose [break].Another same size absolute pro was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay reported.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
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 Key17886504
MDR Text Key325106174
Report Number2024168-2023-10992
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K072708
Number of Events Reported1
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 01/05/2024
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 Number1011921-060
Device Lot Number2061363
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2023
Initial Date FDA Received10/06/2023
Supplement Dates Manufacturer Received01/02/2024
Supplement Dates FDA Received01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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