MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LIFESPAN EPTFE VASCULAR GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number	R06050
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for evaluation since it was discarded by the user.Without the returned device, we remain inconclusive on the exact cause of the malfunction.We have performed a burst test and water entry test on a sample of units from our inventory.All of them passed the minimum specification.Likewise, we have also performed inspection on these grafts.None of them showed any defects.Please note that we perform 100% water entry test of the manufactured graft during our in-process inspection.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.Further, we have not received any other complaints of a similar nature for devices from this lot.We have initated a corrective and preventive action (capa) to address the potential root cause(s) of this defect.The capa remains an active project at this time.
Event or Problem Description
Prior to anastomosis, during preparing the graft, a layer of the graft started to separate when the surgeon cut it across the graft.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT PROSTHESIS
• 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 14717992
• Report Number: 1220948-2022-00053
• Device Sequence Number: 11296563
• Product Code: DSY
• UDI-Device Identifier: 00840663105199
• UDI-Public: 00840663105199
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K130016
• 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): 06/16/2022

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 Model Number: R06050
• Device Catalogue Number: R06050
• Device Lot Number: LVG2837
• 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: 05/17/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown