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

Model Number HJL016-40-N

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

We have not received the section of the graft with the defect for investigation since the section was discarded by the user.Hence, we could not confirm the exact nature of the reported malfunction.Procol vacular bioprosthesis is derived from a single length of bovine mesenteric vein that is chemically cross-linked with glutaraldehyde.Natural variations even in the same graft is possible.Collateral branches are ligated with surgical suture and the graft is inspected under pulsatile flow conditions at simulated physiological internal graft pressure.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 swollen 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.A batch record review could not be conducted at this time since the lot number of the affected graft was not provided.We have also reviewed our complaint history for last 3 years.We have not received any other complaints of a similar nature.Hence, we consider this to be an isolated incident.

Event Description

The procol graft tore during pre-use check.This section with the defect was cut off and the rest of the graft was implanted.There was no harm to the patient as the result of this malfunction.

• Brand Name: PROCOL BIOLOGIC 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 12321636
• MDR Text Key: 268028872
• Report Number: 1220948-2021-00079
• Device Sequence Number: 1
• Product Code: LXA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HJL016-40-N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1