MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOGRAFT POLYESTER VASCULAR GRAFT; VASCULAR PROSTHESIS

Catalog Number	AMC1207
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 crosslinked 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.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.The patient is stable and has been discharged from hospital with no post-operative complications so far.Physician stated he was not concerned during this case but wanted to make us aware of this incident anyways.Some amount of blood is expected to ooze out from the graft after implantation.The hemostasis is expected to be maintained spontaneously without any need for intervention.The time added on to this case as a result of this incident equated to about 10 minutes.At this time, we cannot determine if the graft failed or contributed to this incident since some amount of oozing is expected after implantation of the graft.
Event or Problem Description
Blood was oozing from left limb of the graft near the site of bifurcation once the supporting clamp was removed.

• Brand Name: ALBOGRAFT POLYESTER VASCULAR GRAFT
• Common Device Name: VASCULAR PROSTHESIS
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7523406
• Report Number: 1220948-2018-00033
• Device Sequence Number: 2018224
• Product Code: MAL
• UDI-Device Identifier: 00840663103423
• UDI-Public: 00840663103423
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: Physician
• Device Expiration Date: 06/28/2019
• Device Catalogue Number: AMC1207
• Device Lot Number: 103542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1