MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PROCOL BIOLOGIC VASCULAR GRAFT; VASCULAR GRAFT,

Model Number HJL016-40-N

Device Problem Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

We have received the explanted graft for evaluation.However, we were unable to investigate the returned graft.The graft has already decayed by the time of our device evaluation since it was returned to us without being submergerd in sterile solution.We have also received a picture of the reported defect from the surgeon.In the provided picture, we observed the proximal end of the graft had dilated twice the diameter of its distal section.The procol graft is a natural vein with competent valves.As stated in the ifu, the beveled cut end is the inflow end of the vessel.The graft should not be implanted or flushed in the opposite direction of flow as competent valves may cause excessive pressure and damage the integrity of the vessel.Our inquiry with the implanting physician revealed that he believed that he had implanted the device in the correct orientation.But the picture provided conflicted with that description.Therefore, we are not conclusive on the exact root cause of this failure.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.Hence, we consider this to be an isolated incident.Please note that each graft is pressurized between 2.7-4.0 psi ( 139 - 206 mmhg) during the inspection process.If pressure exceeds 4 psi, the vessel is rejected for 'overpressurized' and discarded.Under a pressurized condition, each graft is inspected by the manufacturing operators for any presence of hole, tear or swelling.An od gage is passed over the entire length of the vessel.If any section of the graft appeared to be dilated or did not pass through the gage smoothly, then that section of the graft is rejected by the technician.Each graft is again inspected by the qc technician for these attributes.Physician implanted another procol vascular graft without any issue.

Event Description

Surgeon used a procol vascular bioprosthesis for creating a bridge graft for vascular access in a dialysis patient.After completion of arterial anastomosis, when surgeon removed the clamp and the graft was under arterial pressure, he observed the proximal end of the graft had dilated.

• Brand Name: PROCOL BIOLOGIC VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT,
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, ma ; 2212266152
• MDR Report Key: 9729589
• MDR Text Key: 185004755
• Report Number: 1220948-2020-00021
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00840663108688
• UDI-Public: 00840663108688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: HJL016-40-N
• Device Catalogue Number: HJL016-40-N
• Device Lot Number: PVB1044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• 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