MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC LIFESPAN EPTFE VASCULAR GRAFT; CAROTID SHUNT

Model Number	QT47050
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the graft for investigation.The patient received the graft on (b)(6) 2021 and it occluded on (b)(6) 2022.It could not be confirmed if the graft was accessed for hemodialysis during this period.We have sent a list of follow-up questions to the hospital but have not yet received a response.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.Graft incorporation involves the graft becoming densely fibrosed to soft tissues so that when needle cannulation is performed there is no potential space for hematoma formation.As stated in the ifu, we recommend using a tunneler to create a tissue tunnel that closely approximates the graft diameter.An oversized tissue tunnel may result in delayed or insufficient perigraft tissue attachment and may promote perigraft seroma formation.The ifu also properly warns users about life-threatening complications which may occur in conjunction with the use of any vascular prosthesis include, but are not limited to excessive suture hole bleeding, thrombosis, thromboembolic complications, infection, ultrafiltration or perigraft seroma, swelling of limbs, pseudoaneurysms, perigraft hematomas, skin erosion, steal syndrome, preoperative hemorrhage, aortoenteric fistula.
Event or Problem Description
Patient has a lemaitre graft implanted on the (b)(6) 2021.Patient came back to theatre as the graft got blocked.Dr.(b)(6) found that the graft did not incorporate and had to remove the graft.Graft was send for mcs.No organism grown.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Common Device Name: CAROTID SHUNT
• 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: 13808197
• Report Number: 1220948-2022-00018
• Device Sequence Number: 16665456
• Product Code: DSY
• UDI-Device Identifier: 00840663105311
• UDI-Public: 00840663105311
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: QT47050
• Device Catalogue Number: QT47050
• Device Lot Number: LVG2989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown