MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD AORTIC ARCH WOVEN; VASCULAR POLYESTER GRAFT

Model Number HEWAA2410080810/1

Device Problem Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

The review of the device history records is being performed.It was reported that the explanted graft is available for evaluation and it is being send to an external laboratory for analysis.A follow up report will be sent upon completion of the investigation.

Event Description

On (b)(6) 2006, a thoracoabdominal aortic surgery was performed and an intergard woven aortic arch (four-branched graft) was implanted.It was reported that blood leaking occurred due to a rupture of the non-anastomotic area.The surgeon suspected the bleeding was from the reference line of the 24 mm main graft.On (b)(6) 2018, a reoperation was performed in order to replace the graft.It was unknown how much blood leaked.The surgery was completed and it was reported that the patient's condition was stable.

Manufacturer Narrative

(3331/213) 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.(10/213) because of the adhesion after 12 years of implantation, the removed graft turned out to be fragments.Macroscopic pictures of the suspected bleeding location were analyzed by our textile manufacturing supervisor on august 3, 2018.Threads coming out of the structure of the product were observed, this being caused by the cutting of the product.The pictures of the inner side show that the textile structure as well as the seams that are visible in the pictures are very well preserved after 12 years of implantation: no anomalies noted.The outer surface is not analyzable because it is covered with human tissue.(4112/3221) ct scan images were provided by the user in order to confirm bleeding location.They were received on august 6, 2018.The corporate medical officer carefully reviewed these images along with an expert ct surgeon but they were both unable to identify the blood leakages.No findings are therefore available.(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(4315) no conclusion can be drawn.The conducted investigation would tend to indicate that the product was meeting its specification at the time of manufacturing.Corrected data: brand name was missing the word "woven" in brand name section.Explanted date was initially wrongly reported as "(b)(6) 2018".It has been replaced in this report for "(b)(6) 2018".

Event Description

When the patient was brought to the hospital, the blood leakage was occurring from two locations.However, initially, only one location was caught from the images (it was hard to find the second leakage).A stent graft was placed, but the patient still had a pain.Then, the surgeon examined the images and it turned out that a little blood leak was found on the main side as well.Therefore, he ended up performing the re-op.

Manufacturer Narrative

(10/4112/3233) the explanted graft and the ct-scan images were sent to an external and independent laboratory, specialized in vascular grafts, for examination.The macroscopic analysis revealed an area where the textile is externally damaged.The location of this damage corresponds to the area of the blood leakage seen on the ct-scan images.An enzymatic digestion is ongoing in order to perform a microscopic analysis of the observed hole.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

(10/3253) after completion of the enzymatic cleaning, a macroscopic analysis and a microscopic analysis have been carried out.As part of the results, the laboratory mentioned: "the hole is seen on the external surface using an endoluminal light.The longitudinal multi-filament yarns above this hole are broken and the extremities of these broken filaments seems disorganized und blistered.These could indicate a rupture by friction.The analysis of the internal surface of zone 1 shows a clear-cut rupture just under the hole.It remain a hypothesis, but this rupture-type is suggesting that the hole might have been created from the inside of the graft maybe by a surgical instrument or sharp calcification which could have led to a blood leakage creating a pseudo-aneurysm." the conclusions are as follows: "two zones of interest presenting textile degradation were analysed.The external surfaces of each zone presented ruptures and disorganisation of the multi-filaments which suggested friction.Only the first zone presented a hole.On the internal surface just under the hole, a clear-cut of a multi-filament yarn was observed.This rupture-type is suggesting that the hole might have been created from the inside of the graft which could have led to a blood leakage creating a pseudo-aneurysm." to have confirmation on the laboratory theories, the surgeon opinion was asked.The surgeon does not believe that the pin hole was developed with a surgical instrument but thinks calcification might have created it.He also suspected needle puncture to remove air might have been the cause but the actual puncture site was different from the holes site.(4315) no conclusion can be drawn.The conducted investigation would tend to indicate that the product was meeting its specification at the time of manufacturing.The corporate medical officer carefully reviewed the laboratory and surgeon conclusions.He concluded that: "we don't have any other supporting notion about the incidence.Both are theories as there is no conclusive evidence for either.Therefore we should consider both in my opinion.".

• Brand Name: INTERGARD AORTIC ARCH WOVEN
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7306163
• MDR Text Key: 101266244
• Report Number: 1640201-2018-00006
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2009
• Device Model Number: HEWAA2410080810/1
• Device Catalogue Number: HEWAA2410080810/1
• Device Lot Number: 04E13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR