MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-05-16 for ALBOGRAFT POLYESTER VASCULAR GRAFT AMC3022 manufactured by Lemaitre Vascular, Inc..
[108435140]
We have not received the device for evaluation since the device has been implanted in the patient. The physical incubation test (which measures how well the collagen was impregnated into the graft), blood and water permeability previously performed on a different portion of the graft from the same lot number was found to be acceptable. Also, the sister graft which is the another half of the same exact graft had also been implanted successfully and without any reported issues. We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue. All qc tests passed their requirements. We have sold all of the grafts that were manufactured under this lot number. We have not received any other complaints of a similar nature for devices from this lot. Patient has been discharged from the hospital. However, patient is scheduled for follow-up to be examined for any blood clot formation. Protamine sulphate was used to reverse the effects of the heparin. Due to the excessive bleeding, 3 blood transfusions were required to replenish the lost blood. Physician had to use copious amount of glue to reduce the leak.
Patient Sequence No: 1, Text Type: N, H10
[108435141]
During abdominal aneurysm repair, after the anastomosis was performed distally and the aortic clamp was removed, the blood leaked through the entire length of the graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00032 |
| MDR Report Key | 7519388 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-05-16 |
| Date of Report | 2018-05-16 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2014-05-28 |
| Date Added to Maude | 2018-05-16 |
| 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 | 3 |
| Brand Name | ALBOGRAFT POLYESTER VASCULAR GRAFT |
| Generic Name | VASCULAR PROSTHESIS |
| Product Code | MAL |
| Date Received | 2018-05-16 |
| Catalog Number | AMC3022 |
| Lot Number | 99104 |
| Device Expiration Date | 2018-05-28 |
| Operator | PHYSICIAN |
| 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. Required No Informationntervention | 2018-05-16 |