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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA SST GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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ATRIUM MEDICAL CORPORATION ADVANTA SST GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number 25002
Device Problem Delamination (2904)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2015
Event Type  Injury  
Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
 
Event Description
Report from the hospital stated that the graft separated between external and internal walls.Defective portion was cut-off and the remainder of the graft was implanted.
 
Manufacturer Narrative
The returned graft was received and inspected.Two segments were found inside the bio-hazards bags: a full length segment with gds attached, and a short delaminated graft segment.The initial examination revealed that the cover layer of the short graft segment was completely delaminated and separated off the wrapped base graft layer.The delaminated segment measured approximately 7cm in length, while the returned graft measured 38cm in length, excluding gds.Both returned graft segments didn't exhibit any ingrowth of biological tissues, except for a few blood spots on the delaminated segment.Two test samples were then trimmed of the long graft segment and tested for mechanical strength.One test sample was taken from the end of the graft, while the second test sample was taken from the center.The radial tensile strength (rts) and the suture retention strength (srt) were evaluated on these two test samples.The average rts test result of two test samples, which were taken from end and the center of the graft, was 66.87 lbf, while the average srt value was 1.347 lbf.According to product specifications of the graft, the minimum rts value is 60 lbf, while the minimum srt value is 0.6 lbf.Engineering summary/conclusion: the sst graft is a tri-laminate graft.The third layer, which is the cover, is a thin material applied over a wrapped base graft layer.The three layers form a graft with an average wall thickness of 0.011".The internal investigation did not reveal the root cause of the delamination.The device history record and manufacturing process steps of this lot were reviewed and there were no discrepancies found.The rts and srt tests conducted on the returned graft indicated the graft met the required mechanical specifications.
 
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Brand Name
ADVANTA SST GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH 03051
Manufacturer Contact
lori gosselin
5 wentworth drive
hudson, NH 03051-4929
6038645366
MDR Report Key5021834
MDR Text Key23718878
Report Number1219977-2015-00239
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K010517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Report Date 07/29/2015
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? No
Device Operator Physician
Device Expiration Date10/31/2019
Device Model Number25002
Device Catalogue Number25002
Device Lot Number216189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2014
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) Required Intervention;
Patient Age84 YR
Patient Weight65
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