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	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the graft for evaluation since the section of the graft containing the hole was discarded by the surgeon.The remaining portion of the graft has been implanted in the patient.However, we have observed the reported incident in the video that was provided to us.We observed a small hole in the graft when user flushed the graft with saline.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 for holes, broken threads, and any loose fibers in the graft.No defect was noted during the inspection process.A sample of grafts from this lot number were also tested for water permeability and puncture test.All of the samples met its specification.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, but based on the documentation and complaint history review, we do not believe there is a systemic issue with these grafts.It is possible that this section of the graft came in contact with a sharp object during the procedure which could have damaged the graft.Since january 2018- now, we have received a total of 2 complaints where the surgeon observed a hole in the graft.The current rate of occurrence of 0.007% for this failure mode is within our expected rate of occurrence of 0.01%.None of the two reported cases caused any harm to the patient.
Event or Problem Description
During procedure, after completing distal anastomosis, surgeon observed a small hole in one of the bifurcated leg when flushing it with saline.The section of the graft with the hole was discarded.There was no harm to the patient as the result of this incident.

• 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: 11711245
• Report Number: 1220948-2021-00041
• Device Sequence Number: 3549761
• Product Code: MAL
• UDI-Device Identifier: 00840663103430
• UDI-Public: 00840663103430
• Combination Product (Y/N): Y
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 06/28/2026
• Device Model Number: AMC1407
• Device Catalogue Number: AMC1407
• Device Lot Number: 298131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention