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	Exsanguination (1841)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remaining fragments of the involved device were 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 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
When the flow was opened after suturing the graft, the whole length of the graft started to exude blood in great quantity.Despite manual compression, intermittent clamping and replenishment of blood and factors, the patient developed an hemorrhagic shock.The time in the operating room between the completion of the bypass and achieving an acceptable hemostasis was approximately 40 minutes.It committed the patient's life and required intervention to maintain his life.Moreover, it was noticed that the graft frayed when it was cut and when it was firmly held with clamps.Remaining fragments of the graft are available for investigation.A second case was mentioned concerning another patient implanted with a graft in an axillary position as well.The patient was admitted to the intensive care unit and had to be reoperated due to bleeding post surgery (see medical device report 1640201-2019-00003).
Additional Manufacturer Narrative
(10/213) the involved device was returned to an external and independent laboratory for examination.The macroscopic analysis showed no abnormality such as tears, loss of textile cohesion, holes and signs of cut.The scanning electron microscopy (sem) analysis of one selected segment pointed out an abundant collagen material admixed with blood proteins infiltration.(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 : "specimens of the graft were received and sent for examination.The result showed no specific anomalies that could justify the bleeding observed.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." (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: 8252230
• Report Number: 1640201-2019-00002
• Device Sequence Number: 1911835
• Product Code: DSY
• UDI-Device Identifier: 00384401015109
• UDI-Public: 00384401015109
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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: 05/31/2023
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 18F21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 03/28/2019; 09/09/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 04/26/2019; 09/17/2019
• 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: Life Threatening; Required Intervention