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

Catalog Number	R06050
Medical Device Problem Codes	Compatibility Problem (2960); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned for evaluation.However, the provided photos confirmed the report.Based on the current information, it is possible that the issue was caused by surgical conditions and the patient reaction to the implanted material.Based on the location of the cutting of the graft (at the point of cannulation), it is likely that the cannulation technique also caused damage or contributed to the damage to the graft.Per the ifu: "in addition, life threatening complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: excessive suture hole bleeding; thrombosis; thromboembolic complications; infection; ultra filtration or perigraft seroma; swelling of limbs; pseudoaneurysms; perigraft hematomas; skin erosion; steal syndrome; preoperative hemorrhage; aortoenteric; aortoenteric fistula.Rotate cannulation sites to prevent complications such as a disruption of the graft material and formation of a perigraft hematoma or pseudoaneurysm.".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.
Event or Problem Description
It was reported that the product was successfully implanted and the graft was healing very well.However, after 2 months the patient returned to the hospital with pseudoaneurysm.During the operation to repair the pseudoaneurysm, the surgeon found that the graft was cutting from the point of cannulation.The patient is in good condition, the graft has been replaced with a jotec graft, and the situation is now resolved.Implant date: (b)(6) 2024.Explant date: (b)(6) 2024.Lot number: lvg2945.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Common Device Name: 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: 19995660
• Report Number: 1220948-2024-00155
• Device Sequence Number: 8432546
• Product Code: DSY
• UDI-Device Identifier: 00840663105199
• UDI-Public: (01)00840663105199
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: R06050
• Device Lot Number: LVG2945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown