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

Catalog Number HJL016-10-N

Device Problem Improper Flow or Infusion (2954)

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

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

We have received the explanted graft for evaluation and we have confirmed the reported incident.About 2 cm at one end of the graft was found to have dilated to about 12 mm while the rest of the graft remained undilated.There was no valve observed inside the graft that could have otherwise impeded the flow.No major difference in thickness between this section of the graft to other section of the graft was observed.However, this section of the graft appears to have experienced some trauma to the intima of the vein.At this time, we cannot confirm if there was a thrombosis or it was a weak vessel wall that contributed to vessel aneurysm.A histology report comparing this dilated section of the graft to undilated section of the graft is currently pending.Surgeon confirmed that the graft was properly flushed with heparin.As stated in our ifu, adverse events including thrombosis/occlusion of the graft could occur with the use of this vascular access graft.Our procol clinical data had shown that the graft may require intervention prior to 6 months after implant.The results from the preclinical and clinical data provide reasonable assurance that the procol device is safe and effective for patients who already have at least one failed prosthetic access graft.There was no injury to the patient as the result of the incident.A new procol graft was implanted to replace the explanted graft.

Event Description

The graft dilated at the arterial end once the blood flow was introduced into the graft after performing the arterial anastomosis.

• 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; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 8025977
• MDR Text Key: 125748070
• Report Number: 1220948-2018-00093
• 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,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2019
• Device Catalogue Number: HJL016-10-N
• Device Lot Number: 016-T2725-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2014
• 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