• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 1012841-60
Device Problem Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2023
Event Type  malfunction  
Event Description
It was reported that during preparation of a procedure to treat a lesion in the hepatic artery with 80% stenosis.The 8.0/60mm absolute pro self expanding stent system (sess) was being cleaned, when it was noted not loosened and exposed.Another absolute pro self stent was used to complete the procedure.There was no problem noted with the deployment mechanism.There was no device use or patient involvement, and there was no clinically significant delay in the procedure.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.
 
Event Description
Subsequent to the initially filed report, the the device was received.The stent was noted to be partially exposed but not flowered with blood noted inside the sheath and inner member was because the device was inserted in the patient's anatomy.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during preparation/cleaning for use and/or during advancement onto the guide wire resulted in the reported/noted premature activation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: the patient code 2645 has been updated to 2199.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key16619671
MDR Text Key312322476
Report Number2024168-2023-03050
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeCH
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 05/11/2023
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 Number1012841-60
Device Lot Number2092861
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/02/2023
Initial Date FDA Received03/27/2023
Supplement Dates Manufacturer Received05/03/2023
Supplement Dates FDA Received05/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-