MAUDE Adverse Event Report: ARTEGRAFT, INC ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number AG750

Device Problem Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446)

Event Date 08/05/2017

Event Type  Injury  

Manufacturer Narrative

The artegraft (collagen vascular graft) was not returned to artegraft, inc.For evaluation as it remains implanted.A review of the production batch record was performed; no anomalies were identified.All grafts released from product batch 16l298 passed all of the requirements including pressure testing and sterility testing prior to final release to finished goods.Artegraft, inc.Scientific advisor (qualification: m.D., f.A.C.S.) reviewed the case details and stated that "it is my clinical impression that the presence of a klebsiella (esbl) is the reason why the graft deteriorated.A 5 cm defect is not consistent with a tributary failure.There appeared to be a tunnel infection.The anastomosis was intact.When the patient was seen in the office, there was no mention of a pulsatile mass in the thigh." artegraft, inc.Ifu dosage and administration section provides instructions for aseptically remove the artegraft from its container.Additionally, the adverse reaction section states "disruption of anastomoses, especially in the presence of infection, has been observed and, in a few cases, transient low grade fever, the etiology, of which has not been obvious, has been experienced." no confirmed complaint trend was identified related to the issue.All product quality and clinical issues will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.

Event Description

Artegraft, inc.Received an email from an approved distribution representative regarding a possible "ruptured" artegraft (collagen vascular graft).The representative had received a phone call from the charge rn at (b)(6) on behalf of the surgeon (dr.(b)(6) to inform of an issue that occurred with a patient admitted through the er with excessive bleeding from a groin incision.The surgeon gained control of the bleeding and identified a 5cm oval shaped "defect" on the artegraft, approximately 4cm from the arterial anastomoses.The surgeon said it appeared that the graft had "ruptured" in this one area, and that the graft looked like it had "blown out".After the surgeon patched the site, he did a culture of the groin area and noted an infection was present at the time.Follow-up details.The graft was implanted on (b)(6) 2017 for a fem-pop bypass.The patient was seen in the surgeon's office on (b)(6) 2017, clear oozing was identified from the groin incision, culture was done at this time but the results were not returned by the time patient went to er the patient was admitted to er on (b)(6) 2017 for the issue of possible graft rupture; a 5cm "defect" was identified at this time.Dr.(b)(6) patched the artegraft.The patient was swabbed again at the time of surgery on (b)(6) 2017.The swab was positive for klebsiella (esbl) infection.The patient was in isolation in the hospital after surgery and the antibiotics were prescribed to treat the current infection as well as prevent infection in the future.The patient was discharged from the hospital on (b)(6) 2017.Incision and surgery site appeared normal.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer (Section G): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 6849392
• MDR Text Key: 85158574
• Report Number: 2247686-2017-00008
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 0031683700312
• UDI-Public: (01)0031683700312(17)191231(10)16L298-002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: AG750
• Device Catalogue Number: AG750
• Device Lot Number: 16L298-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 77