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

Model Number	HGKAX0808
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intervascular sas (manufacturer) is submitting the report on behalf of maquet cardiovascular, llc (importer), according to the exemption e2017024.It was reported that the product is available for investigation, it should be returned to intervascular for examination.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 investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The hospital reported that during a graft procedure, blood oozed through the body of the graft and had to be removed.A replacement graft was used to complete the procedure.The hospital did not report any patient effects.
Additional Manufacturer Narrative
(10/213) the involved device was returned to an external and independent laboratory for examination.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 impregnated with blood.The lumen is clear and the three extremities have been clean cut probably during the implantation.A slight fibrous deposit can be seen on some points of the graft.Some mildews were observed and are certainly due to the non-storage of the graft in formalin.A blood clot is also observed on one area." 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 were observed which could explain the bleeding noticed during the implantation.Since the graft is impregnated with blood the permeability can't be verified." (11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
Our medical corporate officer reviewed the case, his assessment is as follows : "an extra-anatomic bypass is a valuable alternative for patients with contra-indications for aorto-bifemoral bypass or endovascular procedures.The patient undergoing this procedure are usually severely ill with many associated comorbidities.Pre-operative drug regimen, intra-operative anticoagulation strategy and distal circulatory anatomy could have been, in different ways, influencing the outcome observed.Because of the lack of information provided regarding this factors any further assessment would be speculative.Additionally, no conclusion should be made regarding the successful use of the alternative graft as the device used is made of eptfe with a significant difference in porosity and overall material composition." (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.(22) 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 pre- or intra-operative anti-coagulation regimen.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8639486
• Report Number: 1640201-2019-00029
• Device Sequence Number: 2286285
• Product Code: DSY
• UDI-Device Identifier: 00384401015109
• UDI-Public: 00384401015109
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2019

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: 11/30/2021
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 16M22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Distributor Facility Aware Date: 04/24/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 09/09/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 08/02/2019; 09/20/2019
• 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