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

Model Number	R06050CS
Health Effect - Clinical Code	Embolus (1830)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• MDR Report Key: 10200407
• Report Number: 1220948-2020-00068
• Device Sequence Number: 16411934
• Product Code: DSY
• UDI-Device Identifier: 00840663105243
• UDI-Public: 00840663105243
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K872090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: Health Professional
• Device Expiration Date: 07/28/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/26/2020
• 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