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

Model Number HGKAX0808

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).No review of the complaint device history records and no device evaluation were performed since the product identifier could not be obtained and the involved graft was not available for investigation.No conclusion can be drawn.

Event Description

It was reported that during a vascular surgery, a problem was encountered with the permeability of the involved hemagard axillo-bifemoral graft.After the doctor tunneled the graft inside the patient, the blood started diffused from the whole sides of the graft so he removed it, he used another one.Also, he faced the same problem with a 2nd graft but he managed it in his own way (see manufacturer report 1640201-2018-00012 for the second involved device).No additional information could be obtained at the date of this report.

Manufacturer Narrative

The event occurred in february 2018, however the exact event date is unknown.It was arbitrarily set to on (b)(6) 2018 in date of event.The serial number of the concerned graft is unknown.However the lot number: 17e25 was provided allowing to identify 3 possible grafts for the reported event.(3331/213) a review of the complaint device history records indicated that the 3 possible grafts were processed and inspected according to established procedures and were 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 possible devices indicated values well within product specifications.(11/213) one retention sample coated on the same day and under the same conditions as the possible devices underwent water permeability testing.The test result indicated a value well within product specifications ( 5 ml/cm²/min).(10/213) the involved device was returned to an external and independent laboratory for examination.The macroscopic analysis and the scanning electron microscopy (sem) analysis of selected segments pointed out variable signs of collagen material infiltration with no abnormality such as tears, loss of textile cohesion, holes and signs of cut.(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(67) the cause of the event remains unknown.However, the conducted investigation and testing performed would tend to indicate that the product was not defective.(22) please note that blood leakage is a foreseeable side-effect as indicated in the instructions for use.In addition, the case was submitted to the corporate medical officer for review, together with the second case concerning same patient and reported by same physician (mdr#: 1640201-2018-00012).His medical assessment is as follows: "the event describes the use of two grafts for a axillo-bifemoral surgical bypass.The first graft had a considerable amount of bleeding throughout the body of the graft when the anastomosis were completed and circulation was restored.The surgeon decided to replace the graft with another one.Before implant the physician decided to soak the graft in blood similarly to what was originally performed with non-coated graft several years ago.The graft was implanted in normal fashion and bleeding was noted when the circulation was reestablished although the amount was significantly less.The graft remained implanted and the procedure was completed.No further complications have been described in the complaint recorded.The first implanted graft was sent to a lab for macro and microscopic examination.The result of the analysis did not show any abnormality.There is no mention regarding the patient's pre-conditions.Usually patients in need of this kind of intervention are at a very late stage of the atherosclerotic disease and under significant blood thinning medications.Therefore it could be assumed the bleeding observed is mostly due to the existing coagulation parameters at the moment of the operation and not from a device lack of performances.".

• Brand Name: HEMAGARD KNITTED GRAFT
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7357354
• MDR Text Key: 103030106
• Report Number: 1640201-2018-00011
• 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
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 17E25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 100