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

Catalog Number	AMC1608
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.Per the ifu: "device cannot be exposed to temperatures above 45°c (113°f).Excessive heat will seriously damage the albograft polyester vascular graft and render it unfit for use.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.Gently remove the support spiral, otherwise the collagen film will be damaged.The grafts must be kept in their original packaging until used.They must be kept in a dust free and dry environment and at a temperature between 0 °c /32°f and 30 °c/ 86 °f." the lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.We have not received any similar complaints related to this lot number.
Event or Problem Description
It was reported that the material of the graft started to disintegrate as the suture went through it; further suturing made the graft disintegrate more.Another graft was used to complete the surgery successfully.No injury was reported to the patient.

• 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: 19761147
• Report Number: 1220948-2024-00136
• Device Sequence Number: 18337495
• Product Code: MAL
• UDI-Device Identifier: 00840663103478
• UDI-Public: (01)00840663103478
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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: Health Professional
• Device Catalogue Number: AMC1608
• Device Lot Number: 405193
• 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: 06/17/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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
• Patient Sex: Unknown