MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION 8MMX50CM, TW, H, ADVANTA VXT, GDS

Model Number	22214
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Report received stated that during removal of the external support the advanta vxt graft wall was damaged, particles of the wall material stuck onto the spiral and the graft wall was damaged and weakened.They noticed the damaged wall does not hold the sutures.Product was used for testing purposes and was not used on a patient.
Additional Manufacturer Narrative
According to the reported complaint received the user was performing a bench top assessment with an advanta vxt helix supported graft for non-clinical testing.The actual product was not returned for evaluation and the device history record review found that the product met all specifications.After careful review of the video supplied and the still images of the procedure performed by the technician in the removal of the helix from the advanta vxt graft, it is clear that the instructions for use (ifu) were not followed.Video imagery provided showed that the helix was not removed in accordance with the (ifu).The rings are added to the advanta vxt to improve kink, compression and torque resistance, a physician may choose to remove portions of it for surgical/technical reasons.The ifu states the following steps for the proper removal of the external "rings" or "helix" from the advanta vxt vascular graft: hold the graft flat (horizontal).Take the very distal portion of the ptfe ring with a pair of forceps and slowly pull off the ring at a 45 degree angle, being mindful not to catch the outer soft wrap.If the external support rings are pulled too quickly, it is possible for a small portion of the vxt outer wrap to be removed.Should the outer wrap fray, the physician is still left with the base layer, which will be sufficient to complete the procedure.Conclusion: the overly forceful nature in which the helix was removed and the failure to draw the helix off the graft (secured horizontally) at a 45° angle in a slow and consistent manner led to degradation of the graft.

• Brand Name: 8MMX50CM, TW, H, ADVANTA VXT, GDS
• Common Device Name: 8MMX50CM, TW, H, ADVANTA VXT, GDS
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 6059445
• Report Number: 3011175548-2016-00007
• Device Sequence Number: 16341969
• Product Code: DSY
• UDI-Device Identifier: 00650862222142
• UDI-Public: 00650862222142
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2016

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
• Operator of Device: Other
• Device Expiration Date: 02/17/2019
• Device Model Number: 22214
• Device Catalogue Number: 22214
• Device Lot Number: 404700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 11/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1