MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HGKAX0808
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the product is available for investigation, it should be returned to intervascular for examination once released by mhra.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.Moreover, 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 (< 5 ml/cm²/min).One retention sample coated on the same day and under the same conditions as the involved 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 lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The event took place during an axillo-bifemoral graft operation for a patient with bilateral critical limb ischemia.After tunneling the graft, the surgeon checked for patency (no kinking) with water.There was a good flow but water was leaking from the graft throughout.The surgeon felt it would still leak profusely with blood flowing through the graft therefore it was unsafe to use the graft which carries a significant risk for bleeding.The graft was therefore not used and a different graft was used to complete the surgery.
Additional Manufacturer Narrative
Corrected data: block h.10 for the fu1.An amendment of the laboratory conclusion was made.Hereinafter the amended conclusion."this segment corresponds to a non-implanted graft which have been in contact with human blood.No defect in the textile structure were observed which could explain the excessive permeability noticed during the implantation.Since the graft is impregnated at some points with blood the permeability can¿t be verified at these areas.".
Event or Problem Description
During axillo-bifemoral graft operation for a patient with bilateral critical limb ischemia, the surgeon tried to use a dacron graft 8 mm axillo-bifemoral graft.After tunnelling the graft, the surgeon was checking the graft patency and exclude kinking by injection of heparin saline.The graft was very porous and didn't hold the fluid inside.He felt that it was unsafe to use the graft which carries a significant risk for bleeding.Therefore, the graft was not used and another kind of graft material was used.
Additional Manufacturer Narrative
Corrected data: block b.1, b.2 & h.1.Note that block b.5 has been reworded based on the report sent by the user facility to the mhra.(10/213) the involved device was sent to an external and independent laboratory for examination.A macroscopic analysis was performed.- as part of its pre-cleaning macroscopic observation, the laboratory mentioned that: " a degradation of the graft by the transport and storage can¿t be excluded, since the prosthesis was not immersed in a formalin solution.".- the macroscopic observations showed that: "this segment is at some points impregnated with blood.The lumen is clear and the three extremities have been clean cut probably during the implantation.No defect in the textile structure have been observed during the analysis.".- the laboratory concludes that: "this segment corresponds to a non-implanted graft which have been in contact with human blood.No defect in the textile structure have been observed during the analysis which could explain the bleeding noticed during the implantation.Since the graft is impregnated at some points with blood the permeability can¿t be verified at these areas.".(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
The corporate medical officer reviewed the case.His assessment is as follows: "the surgeon tested the graft with saline before implant.He deemed the graft very porous and decided to not proceed with the implant.He completed the axillo by-femoral procedure with another unspecified graft.The report, from the analysis of the graft returned, did not show any structural anomaly that could justify an increased porosity.It is unclear what criteria was used to deem the device unsafe.Based on the results of the analysis of the graft there is no evidence to support any concerns regarding the graft¿s performance.".Based on this medical assessment and on fda definitions/guidance, this event was reclassified as a product problem/malfunction.No adverse event occurred to the patient, the user intervened before there was any harm to the patient.Corrected data: blocks b1, b2 and h1.(67) the cause of the event remains unknown.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 8674207
• Report Number: 1640201-2019-00031
• Device Sequence Number: 2349254
• Product Code: DSY
• UDI-Device Identifier: 00384401015109
• UDI-Public: 00384401015109
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2019

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
• Operator of Device: No Information
• Device Expiration Date: 06/30/2023
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 18G26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 08/06/2019; 10/07/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/02/2019; 09/05/2019; 10/31/2019
• 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