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

Catalog Number	RS47050
Medical Device Problem Code	Biofilm coating in Device (1062)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Graft was implanted on (b)(6) 2017 in the upper arm.On (b)(6) 2017, thrombectomy was performed to check the performance of the graft.Doctor then found that the graft did not incorporate well and began to scar in.So, he replaced the graft on (b)(6) 2017.Also, he discovered a film on the graft indicating a likely infection.Cultures were then taken but not available as of report date.Doctor had told the sales rep.That the infection could be related to patient's health condition rather than the reaction to the graft.We have conducted a lot history review and did not find any issues noted in the manufacturing, packaging and sterilization process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of similar nature for devices from this lot.Hence, we consider this to be an isolated incident.There was no injury to the patient as the result of this incident.Patient has been discharged from the hospital.Although the investigation is ongoing, it is unlikely that the infection experienced by the patient was related to the graft.It is possible that the patient's health condition along with the physician's technique could have contributed to this incident.
Event or Problem Description
During routine thrombectomy, surgeon discovered an unknown film over the graft after 12 days of implant.The graft was then removed and replaced with a new graft.

• 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: 6888500
• Report Number: 1220948-2017-00055
• Device Sequence Number: 13611305
• Product Code: DSY
• UDI-Device Identifier: 00840663105274
• UDI-Public: 00840663105274
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: RS47050
• Device Lot Number: LVG2252
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/22/2017
• 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