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

Model Number R06050CS

Device Problem Complete Blockage (1094)

Patient Problem Embolus (1830)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

We have received the complaint device for evaluation.However, we were unable to confirm the reported defect with the graft during our evaluation process.Graft was implanted in the patient's arm for av access on (b)(6) 2020.On (b)(6) 2020, surgeon observed a blood clot in the graft during an ultrasound scan.Graft was then explanted on (b)(6) 2020 and was replaced with another lifespan eptfe vascular graft.The occlusion occurred prior to any cannulation for av access.There was no injury to the patient as the result of this incident.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.Our ifu properly warns users about the risks which may occur in conjunction with the use of any vascular prosthesis including thrombosis.As stated in the ifu, complications due to individual patient reaction to an implanted device, or to physical or chemical changes in the components, may necessitate reoperation and replacement (sometimes within hours or days) of the prosthetic device.Careful and continuous medical follow-up is advised so that prosthesis-related complications can be diagnosed and properly managed to minimize danger to the patient.

Event Description

This graft (r06050cs/lvg2327) was implanted in the patient's arm on (b)(6).It was confirmed by echo that there was a part where blood flow was blocked in the lumen of this graft on (b)(6).The surgery was performed to exchange this graft to another graft (r06050cs/unknown lot number) on (b)(6).After the surgery, the patient is fine and no health damage.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, ma ; 2212266152
• MDR Report Key: 10200407
• MDR Text Key: 198322407
• Report Number: 1220948-2020-00068
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00840663105243
• UDI-Public: 00840663105243
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K872090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R06050CS
• Device Catalogue Number: R06050CS
• Device Lot Number: LVG2327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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