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

Catalog Number T07050C50

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/31/2024

Event Type  Injury  

Event Description

The distal end of the graft with the removed spiral support was anastomosed to the right common carotid artery.When the blood flow was released, bleeding from the graft occurred (area where the spiral support was removed).The doctor attempted to stop the bleeding with gauze, but it didn't stop.The bleeding area on the graft was sutured and adhesive was also applied to stop the bleeding.Since the bleeding from the graft surface was stopped, this graft was left in the blood vessel and the procedure was successfully completed.No other complications were reported to the patient.

Manufacturer Narrative

The unused portion of the device was returned for investigation.Inspection of the device found no sign of damage/abnormality that would cause leaking of the graft.The support spiral was able to be removed without any issues and did not cause any damage to the graft surface.It is possible the leakage occurred due to the process of anastomosing the graft to the artery during the procedure.Per the ifu: "when using a graft with removable external ptfe monofilament support, slowly unwind the monofilament at a right angle to the graft.Be careful to avoid removal of the thin spirally wrapped eptfe tape.Rapid unwinding and/or removal of the monofilament support parallel to the axis of the graft may damage the product.Suture technique: disruption of the graft, host vessel, and/or suture lines may occur if appropriate suture techniques are not observed.Utilize a small diameter, tapered, non-cutting needle to prevent bleeding from suture holes." we have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.

• 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 18817602
• MDR Text Key: 336741114
• Report Number: 1220948-2024-00057
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: T07050C50
• Device Lot Number: LVG3493A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2022
• 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
• Patient Outcome(s): Required Intervention