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

Model Number	AMC1407
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the graft for evaluation since the section of the graft containing the hole was sutured and implanted by the surgeon.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.During the manufacturing process, the exact graft was inspected by a quality control inspector on may 24, 2016, for holes, broken threads, and any loose fibers in the graft.No defect was noted during the inspection process.Further, we have not received any other complaints of a similar nature from this lot.At this time, we remain inconclusive about the root cause of the issue.(b)(4).
Event or Problem Description
During an infrarenal aortic replacement, after completing proximal anastomosis, the surgeon observed a defect in the y section of the graft.He observed a hole in between the two bifurcates.It was about 1 mm with a visible mesh defect.The hole was closed with a suture.No other defects were present in the graft.There was no harm to the user or the patient because of this malfunction.

• 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: 12416062
• Report Number: 1220948-2021-00081
• Device Sequence Number: 11632046
• Product Code: MAL
• UDI-Device Identifier: 00840663103430
• UDI-Public: 00840663103430
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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 Expiration Date: 03/28/2022
• Device Model Number: AMC1407
• Device Catalogue Number: AMC2010
• Device Lot Number: 154141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1