ARTEGRAFT AG636

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-02-07 for ARTEGRAFT AG636 manufactured by Artegraft, Inc.

Event Text Entries

[99211318] Device 2 of 2; refer to mdr-2247686-2018-00002 for device 1 of 2. The two artegraft (collagen vascular grafts) were not returned to artegraft, inc. For evaluation as they remain implanted. A review of the production batch record was performed; no anomalies were identified. All grafts released from product batch 16j215 passed all of the requirements including pressure testing and sterility testing prior to final release to finished goods. In follow-up conversations between the distributor representative and the surgeons' staff at (b)(6) hospital, it was stated that the tamper evident seal was in place on the box , the shrink wrap was present on the tube prior to use, and the graft was prepared per the ifu prior to use. Artegraft, inc. Mailed a certified letter to (b)(6) hospital requesting additional information related to the events. To date, no additional information was provided. Artegraft, inc. Chief medical officer (qualification: m. D. , f. A. C. S. ) reviewed the case details and stated that "in the event that a wound infection occurs in the area of the artegraft, increased surveillance must be undertaken. Graft is collagen. Collagen may break down in the presence of pseudomonas, mrsa, e. Coli. " artegraft, inc. Ifu dosage and administration section provides instructions for aseptically removing 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.
Patient Sequence No: 1, Text Type: N, H10


[99211319] Artegraft, inc. Received an email from an approved distributor representative on behalf of a vascular surgeon (dr. (b)(6)) stating that he recently had 2 patients that acquired infections roughly 2 weeks post-op artegraft (collagen vascular graft) implant for peripheral use. This file will capture patient 1 of 2. On (b)(6) 2017 the patient had femorodistal bypass surgery with two 5mm artegrafts. The bypass "went down" and the patient ended up in another facility before coming back to dr. (b)(6). When the patient presented to him roughly 2 weeks post-op, she had pseudomonas. The surgeon mentioned that the graft "dissolved" in a portion where it was infected and had a "big hole" in it. The patient reportedly expired and it was stated that it was "not due to the artegraft".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2247686-2018-00003
MDR Report Key7247266
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2018-02-07
Date of Report2018-04-20
Date of Event2018-01-04
Date Mfgr Received2018-03-21
Device Manufacturer Date2016-11-07
Date Added to Maude2018-02-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CYNTHIA SALTER
Manufacturer Street206 NORTH CENTER DRIVE
Manufacturer CityNORTH BRUNSWICK NJ 089024247
Manufacturer CountryUS
Manufacturer Postal089024247
Manufacturer Phone7324228333
Manufacturer G1ARTEGRAFT, INC.
Manufacturer Street206 NORTH CENTER DRIVE
Manufacturer CityNORTH BRUNSWICK NJ 089024247
Manufacturer CountryUS
Manufacturer Postal Code089024247
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTEGRAFT
Generic NameCOLLAGEN VASCULAR GRAFT
Product CodeLXA
Date Received2018-02-07
Model NumberAG636
Catalog NumberAG636
Lot Number16J215-024
Device Expiration Date2019-09-30
OperatorPHYSICIAN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTEGRAFT, INC
Manufacturer Address206 NORTH CENTER DRIVE NORTH BRUNSWICK NJ 089024247 US 089024247


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2018-02-07

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