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

Model Number HEWAA2810080810/1

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 01/20/2019

Event Type  Injury  

Manufacturer Narrative

The complaint device has been received and was inspected by our qa manager.The product is cut in two.The biggest part (body of the aortic arch + 3 branches) was not used and does not have any apparent defects.The smallest part (one of the lateral branches of the aortic arch) was used and was covered in blood.However, it was not possible to rule on the conformity of the product since the structure may have been damaged by a fixing system still present around it.This used portion was sent to an external and independent laboratory for examination.A review of the complaint device history records is ongoing, results are pending.The review of post-marketing historical data indicated that no other 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 Description

A blood leakage during a graft implantation procedure was reported.The graft was removed after multiple leakages were found and it was replaced by a new graft.

Manufacturer Narrative

(4102/213) 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).(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

(10/3233) the small bloody fragment of the graft was used as a perfusion branch for extra-corporeal circulation (cec).This was confirmed by our corporate medical officer based on the pictures provided.After an internal qa inspection (described in initial report), this segment was analyzed by an external and independent laboratory.Their first observations are as follows: the segment is rigid because it has been impregnated by blood the collagen coating is no more seen, this is probably linked to the presence of blood and the fact that the graft was not immersed in formalin a black multifilament is observed near one extremity, it was probably used to bind the cannula to the cec two hose clamps are present and between them, the graft is collapsed and elongated a rehydration is ongoing to microscopically analyze the graft without its rigidity.(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.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).(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

(10/213) the rehydration of the explant made it possible to analyze the graft without its rigidity but no further observations on the textile structure were made.In their analysis report , the laboratory concludes: "the macroscopic analysis did not reveal any cause for the excessive bleeding but few hypotheses could be made: - the prosthesis is not made to be use for ecc cannula.The main difference is that the patient was non-coagulable during the ecc because of the systemic injection of 3mg/kg of heparin.- the elongation of the graft between the two hose clamps could have weaken the collagen coating.However, this area was not exposed to blood flow but in contact with the cannula.- there is a permeability defect, but this hypothesis cannot be verified since the graft is impregnated with dry blood." in addition, the results of this analysis have been reviewed by the corporate medical officer and his assessment is as follows: "it appears that the graft was used to tight the arterial cannula.Silk sutures and plastic tights were used to secure the graft to the cannula.It could be speculated that since two methods where used to secure it one of the two failed to provide the expected fixation.As a consequence, the graft may have been subjected to increase level of stretch and manipulation leading to excessive bleeding at the securement site.It is still unknown why the surgeon has decided to use only a 8 mm branch graft from an intergard aortic arch graft.Regardless, the graft has been used in an off-label fashion as the device is not indicated for connection of the arteria cannula during an extracorporeal circulation.It should be also noted that the graft used in this fashion is subjected to a very high blood flow (up to 10l/min) producing very high shear stress in the inner lumen potentially damaging irreversibly the collagen coating.In summary, the blood leakage observed by the physician is likely due to the above conditions and not from any performance issue of the device." (67) the conducted investigation suggests that the product was not defective at the time of manufacturing.(24) please note that, as per the product instructions for use, the use of woven vascular grafts as a conduit for cannulation is not an approved indication.Indeed, intergard woven vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the aorta both thoracis and abdominal, visceral arteries and peripheral arteries.

• Brand Name: INTERGARD AORTIC ARCH WOVEN
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8383241
• MDR Text Key: 137586640
• Report Number: 1640201-2019-00014
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010753
• UDI-Public: 00384401010753
• Combination Product (y/n): N
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2022
• Device Model Number: HEWAA2810080810/1
• Device Catalogue Number: HEWAA2810080810/1
• Device Lot Number: 17H03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention