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

Model Number IGW0030-30

Device Problems Flaked (1246); Product Quality Problem (1506); Contamination /Decontamination Problem (2895)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

It was reported to intervascular that when an intergard woven straight graft 30cm x 30cm was prepared for use, the customer noticed that it was not suitable for use due to the color change observed on the graft.In addition, it was reported that a hair was observed on the graft.¿ moreover, it was reported that particles in the graft were spilled.The customer wanted to prevent the spillage by cutting a portion of it.However, the particles continued to fall out from the cut parts.

Manufacturer Narrative

(10/3233) it was reported that the product is available.Currently, the shipping process is ongoing.A visual product inspection is scheduled.(4109/3233) the review of historical data indicated that one other similar complaint (b)(6) was reported by the same customer for the same sterilization lot number 21h19 and at the same date.Refer to initial mdr mfg report #(b)(4).The investigation is still ongoing.(3331/213) the device history records review concluded that there was no non conformance/planned deviation in relation with the event (11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.Evaluation anticipated but not yet begun.

Manufacturer Narrative

(10/4248) the involved device was returned to intervascular.A visual inspection was performed by two quality control (qc) technicians.They observed that the returned product has been manipulated and cut.The observation results were analyzed by the quality assurance supervisor, who concluded that given the condition of the returned graft, it is not possible to investigate further.(4109/213) the review of historical data indicated that another similar complaint (b)(4) about stain on the graft for lot number 21h19 was reported by the same customer and at the same date.The investigation findings of complaint #(b)(4).Concluded that the involved device was in compliance with the product specifications.(4315/19) based on the investigation findings, no conclusion can be drawn on the exact origin of reported incident.Following the inspection results of returned device, it was observed that the customer had handled and cut the product.Considering its condition, it is not possible to determine the cause of the customer's observation and no further investigation can be carried out.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.

Event Description

Complaint #(b)(4).

• Brand Name: INTERGARD WOVEN STRAIGHT
• 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: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 16975686
• MDR Text Key: 316008565
• Report Number: 1640201-2023-00013
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000266
• UDI-Public: (01)00384401000266
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGW0030-30
• Device Catalogue Number: IGW0030-30
• Device Lot Number: 21H19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1