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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM); PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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THORATEC CORPORATION VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM); PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number 1010880
Device Problem Infusion or Flow Problem (2964)
Patient Problem Stenosis (2263)
Event Date 11/17/2021
Event Type  Injury  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .
 
Event Description
It was reported that on (b)(6) 2021, since stenosis on the v side was suspected, angiography was performed, and the luminal part of the artificial blood vessel was concave, and dissociation was confirmed.On (b)(6) 2021, the suspected dissociation was removed and replaced with a thoratec graft.
 
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .
 
Event Description
It was reported that on (b)(6) 2021, since stenosis on the v side was suspected, angiography was performed, and the luminal part of the artificial blood vessel was concave, and dissociation was confirmed.On (b)(6) 2021, the suspected dissociation was removed and replaced with a thoratec graft.
 
Manufacturer Narrative
Section e: this event occurred at (b)(6) hospital in (b)(6).Manufacturer's investigation conclusion: the report of stenosis and dissociation of the graft layers could not be confirmed.The customer reported that an angiography was performed on (b)(6) 2021 due to suspicion of graft stenosis.The luminal side of the graft was reported to be concave and there was believed to be a dissociation.The suspected dissociation was removed and replaced with a new graft on (b)(6) 2021.The replaced section of graft was reportedly disposed of and no product is available for investigation.The cause of the reported stenosis and graft issue could not be determined.Review of the device history records showed no deviations from manufacturing or quality assurance specifications, including visual and dimensional inspection.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu).Occlusion, stenosis, and thrombosis are listed as potential complications with the use of a vascular prosthesis.Intragraft obstruction is listed as a potential complication in table 2 in the summary of vectra vag clinical experience section of the ifu.The ifu states that the graft should not be pulled (axially elongated) or stretched during handling at implantation.The graft should be trimmed long enough to prevent stress on the anastomosis and allow for a full range of body motion when implanted.Excessive elongation or stretching of the graft will damage the microporous layers of the graft.No further information was provided.The manufacturer is closing the file on this event.
 
Event Description
The cause of the obstruction was seemingly the peeling of the inner layer.The patient was stable and there were no plans for future care.
 
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Brand Name
VECTRA VASCULAR ACCESS GRAFT (D: 5MM, L: 40CM)
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key13014146
MDR Text Key286126674
Report Number2916596-2021-07425
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00813024012269
UDI-Public813024012269
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K001927
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2020
Device Model Number1010880
Device Lot Number151104-2
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2015
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 Outcome(s) Hospitalization; Required Intervention;
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