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

Model Number R06050

Device Problem Complete Blockage (1094)

Patient Problem Thromboembolism (2654)

Event Date 06/12/2023

Event Type  Injury  

Event Description

It was reported the patient developed graft thrombosis a day after the procedure on (b)(6) 2023.The case was for avf in the thigh using lifespan r06050.The surgeon was supplied with a replacement and performed a second surgery on (b)(6) 2023.The patient stabilized post procedure and was doing well.

Manufacturer Narrative

We have not received the graft for investigation.Hence, we could not conclusively determine the root cause of the reported incident.The reported issue is a possible complication as a result of using this product.As stated in the ifu: complications due to individual patient reaction to an implanted device, or to physical or chemical changes in the components, may necessitate reoperation and replacement (sometimes within hours or days) of the prosthetic device.Careful and continuous medical follow-up is advised so that prosthesis-related complications can be diagnosed and properly managed to minimize danger to the patient.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.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington 01803 ; 7814251683
• MDR Report Key: 17308557
• MDR Text Key: 319010246
• Report Number: 1220948-2023-00124
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00840663105199
• UDI-Public: (01)00840663105199
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R06050
• Device Catalogue Number: R06050
• Device Lot Number: LVG3595
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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
• Patient Outcome(s): Required Intervention