MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED; VASCULAR POLYESTER GRAFT

Model Number HGKAX0808

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Failure of Implant (1924); Blood Loss (2597)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

The involved device was sent to an external and independent laboratory for examination.The investigation is ongoing.A review of the complaint device history records indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating records.The review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications.One retention sample coated on the same day and under the same conditions as the complaint device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).The review of post-marketing historical data indicated that no other similar complaint was reported for the same product family and same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

During an axillo-bifemoral graft implantation procedure, when the surgeons flushed the graft, blood leakage was observed through it.No consequence for the patient has been reported.Another graft was used.

Manufacturer Narrative

(10/135) the explanted graft was analyzed by an external and independent laboratory.The macroscopic analysis showed no textile abnormality such as tears, loss of textile cohesion, holes or signs of cut.However, the scanning electrode microscopy (sem) analysis performed on two selected segments showed heterogeneous signs of collagen material infiltration at the external side of the graft segment with areas showing evident presence of collagen material and areas with poor collagen material.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

(4315) the investigation results were reviewed and discussed with our r&d director and corporate medical officer.Considering the different manipulations and contact with fluids, it is not abnormal that the external collagen layer of the product appears affected.Therefore, the product analyzed may not be fully representative of the product at the time of implantation.The cause of the event remains unknown.However, the conducted investigation, which included all available information and the testing we performed, suggests that the device was not defective at the time of manufacturing.Blood leakage is a foreseeable side-effect as indicated in the product instructions-for-use, and may be related to several causes including the preexisting condition of the patient and preoperative anti-coagulation regimen.

Manufacturer Narrative

Corrected data : block b1 : this event is only an adverse event, because the use of the device has resulted in an adverse outcome in a patient.Block h6 : the patient code is not a "blood loss" (2597), according to the narrative below the patient code is an "implant failure" (1924).Additional narrative : our medical corporate officer reviewed the case, his assessment is as follows : " it appears the surgeon flushed the graft with heparinized saline before implant.The graft returned is completely white therefore i assume it has not been in contact with blood.He/she observed a significant amount of blushing/oozing therefore a decision was made to use a different graft to complete the procedure.The graft was returned and sent for further analysis.Namsa made a macroscopic as well as an ultrastructural (sem) analysis of the specimen.The result shows normal structure, absence of tears and inhomogeneous content of collagen in the graft.I observed the sem pictures.The areas of "poor collagen content" contain collagen imbibed in the fibers but not between them like in the more collagen reach areas.It is very difficult to draw a conclusion on this case because the criteria used from the surgeon to judge the graft blushing/oozing is unknown and certainly subjective due to personal experience.It is also unknown if the graft implanted and open to blood would have exhibit a similar behavior or it would have performed satisfactorily.Additionally, the manipulation of the graft could have caused the inhomogeneous collagen content aspect observed in some areas." (4315) the cause of the event remains unknown.(67) however, the conducted investigation, which included all available information and the testing we performed, suggests that the device was not defective at the time of manufacturing.

• Brand Name: HEMAGARD KNITTED
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8114439
• MDR Text Key: 128724592
• Report Number: 1640201-2018-00027
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401015109
• UDI-Public: 00384401015109
• Combination Product (y/n): N
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2019

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 17A05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 03/28/2019; 05/14/2019; 09/09/2019
• Supplement Dates FDA Received: 04/26/2019; 05/24/2019; 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention