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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 1011922-040
Device Problems Difficult to Advance (2920); Activation Failure (3270); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported the procedure was to treat a heavily calcified and mildly tortuous lesion in the iliac artery.The 7.0x40mm absolute pro self expanding stent system (sess) was advanced through the 6fr sheath however got stuck due to the tight lesion compressing the sheath.The sess was able to advance to the lesion however would not deploy.The sess was removed from the patient when it was noted the sheath covering the stent was torn.A non-abbott stent was used 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
The device was returned for analysis.The reported material split, cut or torn was able to be confirmed.The reported difficult to advance/position and the reported failure to deploy the stent 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 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 interaction as the tight lesion was compressing the sheath resulted in the reported difficult to advance/position and the reported activation failure.Interaction and/or manipulation of the device resulted in the reported material split, cut or torn/noted sheath separation and the noted wrinkled sheath.The noted multiple bends on the jacket likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key13012769
MDR Text Key287922883
Report Number2024168-2021-11634
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K072708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/01/2022
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 Date09/30/2022
Device Catalogue Number1011922-040
Device Lot Number9100461
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2021
Initial Date FDA Received12/15/2021
Supplement Dates Manufacturer Received01/31/2022
Supplement Dates FDA Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
6FR SHEATH; TERUMO STIFF GLIDE WIRE - 300
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