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

Catalog Number	HJL016-40-N
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have received a piece of the explanted graft for evaluation.However, the returned section of the graft was not the section that had occlusion.The inner surface of the graft looked smooth and did not show any sign of occlusion.Doctor had also mentioned that he found a hole in the graft.Doctor thinks he might have punctured the graft while dissecting.So, he replaced that section of the graft with a different procol graft.A thrombectomy is usually performed to remove the thrombus using standard atraumatic percutaneous or surgical techniques 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 month 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.(b)(4) units from this lot has been sold.We have not received any other complaint related to this lot or any other procol lot for a similar incident.Hence, we consider this to be an isolated incident.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 or Problem Description
The procol vascular bioprosthesis graft was placed in the lower right arm for av access.After three weeks of implant, when doctor attempted to declot the graft, he found that the graft had occluded at the apex of the graft.He also found a hole in the graft.So, he sewed both ends and abandoned the graft.

• Brand Name: PROCOL BIOLOGIC VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7187515
• Report Number: 1220948-2018-00001
• Device Sequence Number: 13476786
• Product Code: LXA
• UDI-Device Identifier: 00840663108688
• UDI-Public: 00840663108688
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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?: No
• Operator of Device: Physician
• Device Catalogue Number: HJL016-40-N
• Device Lot Number: 016-T2791-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention