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

Catalog Number	AMC1608
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the albograft wall was leaking after being closed with sutures for an abdominal aortic aneurysm (aaa) procedure.Leakage occurred from the graft resulting in longer operation time and blood loss.An alternate graft was used to complete the procedure.No further complication or injury was reported to the patient.
Additional Manufacturer Narrative
The product was discarded at the site and therefore not available for evaluation.As a result, the exact root cause of the reported issue could not be confirmed.It is possible that handling of the device and procedural factors contributed to the reported issue.During manufacturing, all devices are porosity tested to ensure the product conforms to specifications and does not leak during testing.As noted in the ifu: for suturing, cylindrical needles are recommended; although taper cut or other cutting needles are not contraindicated.Avoid overstretching the graft; gently expand the graft to smooth the folds.Avoid damaging the graft when handling, use atraumatic clamps and appropriate instruments (e.G.Vascular clamps).Avoid using these instruments with undue force, otherwise the collagen coating or fabric will be damaged.Review of the device history record did not identify any issues that would cause the reported issue.

• Brand Name: ALBOGRAFT POLYESTER VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 19617006
• Report Number: 1220948-2024-00119
• Device Sequence Number: 7097033
• Product Code: MAL
• UDI-Device Identifier: 00840663103454
• UDI-Public: (01)00840663103454
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: AMC1608
• Device Lot Number: 378572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown