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

Model Number R08080C80

Device Problems Material Discolored (1170); Failure to Seal (4070)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Therefore, the reported event could not be confirmed and the root cause could not be determined.No evidence of the graft discoloring or failing was provided.Review of the ifu found the following information related to the closure of the device after needle puncture: anastomose the graft as perpendicular to the axillary artery as possible to minimize stress.The anastomotic angle should be as small as possible and should not exceed 25° relative to the cut edge of the graft.As stated in the complaint, a 23 gauge needle was used at an angle of 30 degrees.This exceeds the recommended angle of 25 degrees, which could have caused difficulty in the closure of the needle puncture that was reported.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.Additionally, we have not received any reports of similar issues occurring for this lot.

Event Description

It was reported lifespan eptfe vascular graft moistens and discolors to red after implantation.Furthermore, there is no spontaneous closure of needle puncture after deairing even after pressure for more than 30 minutes.A gauge 23 needle angulated to 30 degrees was used during deairing.Graft was anastomosed to the axillary artery right to the right femoral artery.Crossover bypass femoral artery to femoral artery done.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Type of Device: 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16397441
• MDR Text Key: 310160530
• Report Number: 1220948-2023-00018
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00840663105649
• UDI-Public: (01)00840663105649
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2023

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
• Device Operator: Health Professional
• Device Model Number: R08080C80
• Device Catalogue Number: R08080C80
• Device Lot Number: LVG3437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1