MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN AORTIC ARCH; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HEWAA2610080810/1

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

It was reported to intervascular that when the doctor opened the package, he found that there was wall separation on the inner side of the graft main body.So he used the other graft instead to complete the operation.(b)(4).

Manufacturer Narrative

Additional information regarding the event was provided.The graft was not manipulated and was not dipped into any liquid.The surgeon described the issue as "falling debris on the inner side".(4112/3233) an analysis of the temperature and humidity records from the different stakeholders (logistic company, local distributors) is being performed by the qa supervisor.The conclusion is pending.(11/213) one retention sample from same lot and coated on the same day and under the same conditions as the involved device was visually inspected by qa supervisors and technicians.No anomaly was found.The sample is conform to the specifications.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

See initial mfg report #1640201-2022-00015.Complaint #(b)(4).

Manufacturer Narrative

(10 / 4248-170-193) the involved device was returned to intervascular for examination.A visual inspection was performed by the qa manager, it concluded that : - that only a small part of the product was received; - that the 2 sides of the sample were not cut with a thermocutter; - that the internal collagen is indeed detached from the prosthesis.However, given the condition of the sample, it is not possible to conclude on the cause of this defect: - poor storage; - incorrect cutting of the prosthesis; - incorrect handling of the prosthesis; - manufacturing defect (such a defect would have been caught during the qc step).(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint # (b)(4).

Manufacturer Narrative

(3331/4248-170) as part of the non conformity report, new elements (complaints and production records) have been reviewed by the qa manager: a review of the similar complaints on the product family over the last 5 years.A review of complaints observed on sterilization lots 21j02 as well as the 2 lots manufactured before or after 21j02.A review of the storage conditions at the hospital but no new data has been made available by the hospital.However, the hospital used other intervascular products stored during the same period as the one complained about.Analysis of the reject rate of the same defect over the manufacturing period of the complaint product.A station observation of the practices of the coating teams through quality control with respect to the arches related to the defect noted by the customer was conducted.These new elements indicate that : it is an isolated case: no other complaint for a similar defect having been received on an aortic arch product over the last 5 ; complaint (b)(4) is the only one we have received on lot 21j02 as well as on the 2 lots manufactured before or after 21j02.The storage conditions at the hospital do not appear to be at issue, as the hospital used other intervascular products stored during the same period as the one complained about.The analysis of the rejection rates as well as the shift observation do not reveal anything abnormal.This deeper investigation therefore confirms the hypotheses raised by the qa manager following the return product sample inspection.Specifically, given the condition of the sample (partial and degraded sample of the prosthesis), it is not possible to conclude on the cause of this defect: poor cutting of the prosthesis ; incorrect handling of the prosthesis; manufacturing deviation (such a defect would have been caught during the qc stage).(4315) no conclusion can be drawn on the exact origin of the defect.Based on the investigation results, the cause of the event could not be determined since the condition of the returned device (partial and degraded sample of the graft) does not allow to determine the origin of the problem.It could be related to the handling of the product (incorrect cutting or incorrect handling of the device) or to a manufacturing deviation (such a defect would have been caught during the qc stage).

Event Description

Complaint #: (b)(4).See mfg reports 1640201-2022-00015.

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 14371237
• MDR Text Key: 300057772
• Report Number: 1640201-2022-00015
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010746
• UDI-Public: (01)00384401010746
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEWAA2610080810/1
• Device Catalogue Number: HEWAA2610080810/1
• Device Lot Number: 21J02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1