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

Model Number	IGK1407
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/30/2018
Type of Reportable Event	Serious Injury
Additional 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.Moreover, the review of the water permeability testing records of products coated on the same period/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.A video of the surgery was provided by the user, showing evidence of the blood leakage.The corporate medical officer carefully observed this video and commented that "because of the two branches are clamped together and at 90 degrees angle from the proximal anastomosis, it is difficult to accurately discriminate where the bleeding is coming from.It does appear that it is coming mostly from an area at the graft bifurcation and to be a continuous stream with pulsatile flow characteristics (not diffused)." the comments from r&d are the following: "at a first glance, it looks like the bleeding was mostly originating from the crotch, however, looking at a lower speed, it seems that bleeding first occurred on the legs before affecting the crotch." the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
After the bifurcated graft was placed in the patient, blood oozed from all over the graft.The amount of blood leakage is unknown.The surgeon replaced it with another graft with reference igk1608 (i.E.One with a larger diameter) and no blood leakage occurred with this second graft.The surgery was prolonged for 15-20 minutes.The graft is available for investigation.A video of the bleeding is available for investigation.The patient's condition is stable.
Additional Manufacturer Narrative
The returned 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.Specifically, no significant textile changes was evidenced at the bifurcation area.At the basis of suture line, accumulation of blood material could be detected.The scanning electron microscopy (sem) analysis of two selected segments (one of each leg of the bifurcated graft) showed massive blood material infiltration that hindered appraisal of the collagen material.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
(4315) the case has been entirely reviewed by our corporate medical officer, who states that, "considering all the information [.], it is not possible to make any further statement regarding the cause of the bleeding".The cause of the event remains unknown.However, the conducted investigation suggests that the device was not defective at the time of manufacturing.

• Brand Name: INTERGARD 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: 8304062
• Report Number: 1640201-2019-00006
• Device Sequence Number: 53386
• Product Code: DSY
• UDI-Device Identifier: 00384401000471
• UDI-Public: 00384401000471
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 02/28/2022
• Device Model Number: IGK1407
• Device Catalogue Number: IGK1407
• Device Lot Number: 17C02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 05/02/2019; 06/21/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 05/29/2019; 06/26/2019
• 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
• Patient Age: 80 YR