MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for ALBOGRAFT POLYESTER VASCULAR GRAFT AMC1608 manufactured by Lemaitre Vascular, Inc..
[130475386]
We have not received the graft for evaluation. Hence, we could not conclusively determine the root cause of the defect. The patient had prior history of perigraft seroma (pgs) with a different graft ( different manufacturer ) as well that was initially used to treat his abdominal aortic aneurysm. Even after the previously implanted graft (different manufacturer) was replaced with the albograft polyester vascular graft (catalog# amc1608; lot# 180381 serial number# (b)(4)), skin eczema and perigraft seroma persisted. The patient was responsive to a prescribed medication for more than a year. Perigraft seroma (pgs) is a rare complication that can occur after placement of any vascular graft. It is a collection of a sterile, clear and acellular liquid around the prosthesis. The incident rate has been estimated at 4% in extra-anatomic bypass and 0. 7%-0. 8% in anatomic bypass of the lower limbs (2,6). In a study conducted by ajith k. Kadakol md and his team, 111 study subjects identified between 1995-2009 underwent an aortic reconstruction- 13 had dacron grafts while 98 had polytetrafluoroethylene (pfte) grafts. Twenty patients (18%) had pgs, all of whom had ptfe grafts (2). The cause of pgs remains unclear, but involves a failure of normal graft healing/incorporation and/or transudation of fluid through graft pores (3,4). Such seromas have been noted after most types of vascular reconstructions, but have usually been recognized and associated with subcutaneously tunneled grafts - axillofemoral bypass and dialysis access grafts (3, 5). Other possible predisposing factors highlighted in the literature include improper handling of the graft at the time of reconstruction (1,4), high blood pressure, low blood viscocity, and low-grade patient allergy to the graft material(7). 180 albografts from this lot were released for sale. We have already sold all of the grafts between march 2017 - november 2018. This is the only complaint we have received for this lot number. Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident. All of the quality control tests passed with expected values. Specifically, the physical incubation test (which measures how well the collagen was cross-linked), blood permeability and water permeability tests, demonstrated that the grafts from this lot performed as expected at the time of release. From the information obtained in our investigation and the successful lot testing results noted above, we believe that the device was performing within its specification limits for acceptability (grafts have a permeability requirement of <0. 1ml/min/cm2 at 120 mmhg). We have also performed alpha ii fourier transform infrared spectroscopy (ftir) on two of the newly released albografts ( part #amc1608 lot # 228721 and part# amc1608 lot# 228715) to confirm any presence of isobutyl 4-hydroxybenzoate in the albograft polyester graft, the compound that was found in the patient's blood. The ftir analysis indicates the absence of isobutyl 4-hyroxybenzoate on both the inner and outer portions of the albograft vascular graft samples. The graft sample spectra displayed a different spectral profile than the spectrum of isobutyl 4-hydroxybenzoate. The test concludes that the source of 4-hydroxybenzoate that was found in the patient's blood was not from the graft but some other sources. Although we are inconclusive about the root cause of this incident, we believe that the albograft vascular polyester graft did not cause or contribute to this incident. Based on review of the literature, it is possible that the isobutyl-4-hydroxybenzoate (the compound which we have proved to be absent from our albograft vascular grafts), which is known to be an allergen could have caused or contributed to this incident. The rate of occurrence for such types of incident is (b)(4) for the lifetime of this device. The current rate of occurrence is in line with the rate of occurrence estimated in the literature. No corrective action is required at this time. References: blumenberg rm, gelfand ml, dale wa. Perigraft seromas complicating arterial grafts. Surgery 1985; 97: 194-204. Ajith k. Kadakol md, timothy j. Nypaver md, judith c, lin md, mitchell r, weaver md, joseph l. Karam md, daniel j reddy md, georges k. Haddad md, alexander d. Shepard mdfrequency, risk factors, and management of perigraft seroma after open abdominal aortic aneurysm repair. S. S. Ahn, h. I. Machleder, r. Gupta, w. S. Mooreperigraft seroma clinical, histologic, and serologic correlates am j surg, 154 (1987), pp. 173-178. W. Bolton, j. Cannonseroma formation associated with ptfe vascular grafts used as arteriovenous fistulae dial transplant, 10 (1981), pp. 60-66. R. M. Blumenberg, m. L. Gelfand, w. A. Daleperigraft seromas complicating arterial grafts surgery, 97 (1985), pp. 194-204. Paes e, vollmar jf, mohr w, et al. Perigraft reaction: incompatibility of synthetic vascular grafts? New aspects on clinical manifestation, pathogenesis, and therapy. World j surg 1988; 12: 750-5. H. A. Kaupp, t. J. Matulewicz, g. L. Lattimer, j. E. Kremen, v. J. Celani graft infection or graft rejection? Arch surg, 114 (1979), pp. 1419-1422.
Patient Sequence No: 1, Text Type: N, H10
[130475387]
A few years ago ( exact date unknown), a patient received a bifurcated aortic prosthesis ( from a different manufacturer ). The patient was diagnosed with a perigraft seroma from this graft. On (b)(6) 2017, the prosthesis was replaced with an albograft prosthesis ( catalog# amc1608; lot# 180381 serial number# (b)(4)). The patient had an allergic reaction to this graft as well. So, the patient was treated for an allergic reaction. The patient responded well to medication. However, since the beginning of (b)(6) 2018, the patient did not respond well to the prescribed medication. A blood test conducted on the patient's blood sample detected presence of methy- propyl-4-hydroxybenzoate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00107 |
| MDR Report Key | 8162158 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2018-12-13 |
| 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 | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALBOGRAFT POLYESTER VASCULAR GRAFT |
| Generic Name | VASCULAR PROSTHESIS |
| Product Code | MAL |
| Date Received | 2018-12-13 |
| Catalog Number | AMC1608 |
| Lot Number | 180381 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-13 |