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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA EPTFE VASCULAR GRAFT
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BARD PERIPHERAL VASCULAR, INC. IMPRA EPTFE VASCULAR GRAFT Back to Search Results
Model Number 40S06
Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)
Patient Problem Thrombosis (2100)
Event Date 05/09/2018
Event Type  Injury  
Manufacturer Narrative
Manufacturing review : a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported through the results of a clinical trial, that approximately one year post placement of a left upper arm vascular graft, the patient experienced thrombosis of vascular access, and was admitted to the hospital same day.Reportedly, a thrombectomy was successfully performed and the patient discharged on hospital day two.
 
Event Description
It was reported through the results of a clinical trial, that approximately one year post placement of a left upper arm vascular graft, the patient experienced thrombosis of vascular access, and was admitted to the hospital same day.Reportedly, a thrombectomy was successfully performed and the patient discharged on hospital day two.
 
Manufacturer Narrative
A complete manufacturing review could not be conducted for the investigation as the lot number is unknown.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.A review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
 
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Brand Name
IMPRA EPTFE VASCULAR GRAFT
Type of Device
EPTFE VASCULAR GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7606694
MDR Text Key111229140
Report Number2020394-2018-00894
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00801741021831
UDI-Public(01)00801741021831
Combination Product (y/n)N
PMA/PMN Number
K004011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number40S06
Device Catalogue Number40S06
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Event Location Hospital
Initial Date Manufacturer Received 05/21/2018
Initial Date FDA Received06/15/2018
Supplement Dates Manufacturer Received10/16/2018
Supplement Dates FDA Received11/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ENOXAPARIN SODIUM, FOLIC ACID; ENOXAPARIN SODIUM, FOLIC ACID; METOPROLOL SUCCINATE, PERINDOPRIL ARGININE; METOPROLOL SUCCINATE, PERINDOPRIL ARGININE; VITAMIN B-COMPLEX,CALCIUM CARBONATE, CINACALCET.; VITAMIN B-COMPLEX,CALCIUM CARBONATE, CINACALCET.; ENOXAPARIN SODIUM, FOLIC ACID; METOPROLOL SUCCINATE, PERINDOPRIL ARGININE; VITAMIN B-COMPLEX,CALCIUM CARBONATE, CINACALCET.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age46 YR
Patient Weight102
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