MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-19 for ADVANTA SLIDER GDS 22115 manufactured by Atrium Medical Corporation.
[70301346]
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[70301347]
Graft was weeping clear fluid not blood after implantation. The clear serum fluid was sweating through the graft continually. The graft had to be explanted and new graft was used.
Patient Sequence No: 1, Text Type: D, B5
[74264881]
Three segments of the graft were returned for evaluation, all of the segments were heavily contaminated with blood. The returned graft segments were all visually inspected for any gross defects, no gross defects were found. The visual inspection confirmed that the outer polytetrafluoroethylene (eptfe) tape layer was present and adhered to the base layer. There was evidence of clamping on two locations along the graft, one on the 4mm end and one on the 7mm end of the tapered graft. It appears that the clamps used on the graft had a serrated surface and caused some localized damage to the outer surface of the graft in the 2 locations. All of the returned graft segments were cut open and 100% of the inner and outer surfaces were inspected under a microscope. No structural defects were found on the inner or outer surfaces of the graft with the exception of the areas where the clamps were used and the anastomosis sites. A thorough review of the device history records (dhr's) for this graft lot was performed, all of the dhr's were found to be complete and accurate and all of the performance testing met the acceptance criteria. The performance test for this failure mode is the water entry pressure test (wep). This test measures the minimum pressure necessary to push water through the wall of the graft. The minimum specification for wep is 155mmhg. The average wep of the samples tested was 328mmhg which is greater than 2x the minimum specification. Summary/conclusion: the investigation found that there were no structural defects on the inner or outer surfaces of the graft. The graft had been clamped in two locations (4mm end and 7mm end) and the clamps used had serrated surfaces. The instructions for use warn against clamping of the graft. Clamping the graft with serrated clamps can cause localized damage to the graft. Also if the clamps were applied while the graft is pressurized it may cause a momentary pressure spike along the length of the graft. It is believed that the improper use of serrated clamps caused the failure. Clinical evaluation: graft weeping may be the result of elongated suture holes or trauma to the graft material that occurs during insertion with the use of serrated clamps. Most weeping will resolve on its own, but occasionally it requires intervention to prevent seroma and infection. The instructions for use (ifu) state that clamping of the graft should be avoided whenever possible and limited to clamps made with soft material. The ifu also states that complications that may occur in connections with the use of any vascular graft include, but are not limited to, weeping.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011175548-2017-00009 |
| MDR Report Key | 6416357 |
| Date Received | 2017-03-19 |
| Date of Report | 2017-03-16 |
| Date Mfgr Received | 2017-04-13 |
| Device Manufacturer Date | 2016-12-08 |
| Date Added to Maude | 2017-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LORI GOSSELIN |
| Manufacturer Street | 40 CONTINENTAL BLVD. |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer Phone | 6038645366 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 40 CONTINENTAL BLVD. |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTA SLIDER GDS |
| Generic Name | 4-7MMX45CM, SW, SH, ADVANTA VXT, GDS |
| Product Code | DYF |
| Date Received | 2017-03-19 |
| Returned To Mfg | 2017-03-09 |
| Model Number | 22115 |
| Catalog Number | 22115 |
| Lot Number | 409925 |
| Device Expiration Date | 2019-12-06 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Manufacturer Address | MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-19 |