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

Catalog Number	QT47040
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We cannot conclusively determine the root cause of the defect since the device is still at the hospital.We sold the device to the hospital on (b)(6) 2016.Out of (b)(4) units manufactured for this lot, all of the devices has been sold.We have not received any other complaints of similar nature for devices from this lot.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.The device is currently at the hospital since the sales rep.Is still waiting to confirm from the surgeon if the patient has a transmittable disease.If the patient do not have a transmittable disease, graft will be shipped back to us for evaluation.We will provide a follow-up report once we perform our investigation and determine the root cause.Device still retained by the hospital.
Event or Problem Description
Surgeon discovered a rupture of about 4 cm on the graft after implantation.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Common Device Name: PROTHESIS, VASCULA GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 6341377
• Report Number: 1220948-2017-00011
• Device Sequence Number: 932853
• Product Code: DSY
• UDI-Device Identifier: 00840663105304
• UDI-Public: 00840663105304
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2017

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: Physician
• Device Expiration Date: 12/28/2022
• Device Catalogue Number: QT47040
• Device Lot Number: LVG1956A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/17/2017
• 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