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

Model Number IGW0008-30

Device Problem Inaccurate Information (4051)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

Pictures of the inner packaging (product blister is transparent) and the outer packaging (box) were provided, showing evidence of the dimension diameter of the graft.Indeed, it appears on the pictures that the diameter of the prosthesis might well be 32-34mm instead of 8mm (to be confirmed when the product is returned).A product non-conformity report was opened in order to take appropriate actions.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 20l12.A review of the complaint device history records is ongoing, results are pending.It was reported that the involved product is available for investigation, it is in transit to the manufacturer.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

It was reported: "when the customer opened the product, they found the actual size didn't match what showed on the label.They used another one instead." it was known later that the surgery has not been delayed.Complaint # (b)(4).

Event Description

See mfg report(s) # 1640201-2021-00042.Complaint #(b)(4).

Manufacturer Narrative

(3331/4245) the device history records review concluded that there was no nonconformance / planned deviation in relation with the event reported.A review of manufacturing records (mfg operations traceability) allowed us to make the assumption that a possible inversion occurred at the primary packaging step between a product reference (b)(4) and a product reference (b)(4) leading to a mislabeling of two products.In the traceability investigation, it is assumed that two products reference (b)(4) might contains, inside the sterile inner packaging a product reference (b)(4).The references of two products identifying are as follows: product ref: (b)(4); lot: 20l12; sn: (b)(6).Product ref: (b)(4); lot: 20l12; sn: (b)6).(10/4245) the involved product was visually inspected by the qa supervisor.His observations are as follows: "the external box of the product is torn, the external and internal lids were not opened.There is a discrepancy between the product, the labeling of the box and the patient set, indeed after checking the diameter of the product on a measuring cone it turns out that the product is an (b)(4)." in conclusion the product is non-compliant due to mislabeling (the primary and secondary labeling is consistent, but the product does not correspond to the labeling) a non-conformity report has been initiated for this issue in order to take appropriate actions.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

(25): the conducted investigation concluded that the product involved in the complaint was not conform due to a product mislabeling occurring because instructions were not strictly followed at primary packaging and primary packaging check steps.A health hazard evaluation (hhe) has been initiated.A capa has been initiated in order to take appropriate actions.

Event Description

See mfg report(s) # 1640201-2021-00042.Complaint #(b)(4).

Manufacturer Narrative

Following the health hazard evaluation (hhe) and the capa investigations, a recall was initiated on april 29, 2022 to withdraw two (2) suspect products from the market.Please note that two (2) devices are suspected and are located in the united states and russia.

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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 13076698
• MDR Text Key: 286648758
• Report Number: 1640201-2021-00042
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000037
• UDI-Public: (01)00384401000037
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K970843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGW0008-30
• Device Catalogue Number: IGW0008-30
• Device Lot Number: 20L12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1