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

Model Number IGW0028-30

Device Problems Use of Device Problem (1670); Defective Device (2588)

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

Event Date 05/30/2022

Event Type  Injury  

Event Description

It was reported to intervascular (complaint #(b)(4)) that during surgery, a graft (igw0028-30) was opened but its length appeared shorter than 30 cm.Therefore, another graft of the same product reference (igw0028-30) was added to the first one to complete the surgery.The surgery was significantly delayed.It was shared that there was a noticeable shortness when the products were opened during the surgery.There is no information about lot/serial number of the graft used and patient information.Since the allegation of shortness involves both implanted products, another mdr is being submitted regarding the second device that was implanted.Please note that due to this event, the stocks of the hospital were checked after the operation and another product of the same product reference, allegedly shorter than 30 cm, was identified.A complaint has been opened in order to handle the event (complaint #(b)(4)) and a mdr is being submitted for this case.

Manufacturer Narrative

The device is not accessible as it remained implanted in the patient.The case was will be reviewed by the medical affairs.The medical review is pending.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

Corrected data: in block b1, following investigation conclusions the field was changed from "adverse event & product problem" to "adverse event".In block h6, medical device problem code, code 2588 was changed to 1670.(4112/3221) the case was reviewed by the medical affairs whose assessment is: "this complaint describes an open surgical procedure requiring an intergard straight vascular graft.The complainant reported that the graft appeared to be shorter than the length stated on the packaging.It was implanted and then to complete the procedure and additional graft (of the same size and length) was implanted.The anastomosis to join the two grafts resulted in a prolonged procedure.The complainant has provided no additional information.It would be important to know the lot number of the devices that were implanted to further investigate if any similar devices were affected.Due to the lack of information provided with this complaint, it is not possible to determine the cause of the ¿shorter than specified length¿ of the grafts that were implanted." (4103/213) one product was returned to intervascular for examination (a product that seemed to present the same defect as the implanted products found in the stock inventory by the hospital ¿ see mfg#: 1640201-2022-00022).It was inspected by the quality assurance department, the conclusion is: "a length measurement of the product was performed as required in our applicable procedure.The length was found to be 31 cm for a specification of 30 cm (-0/+2 cm) which meets the expected length specification as mentioned in the labelling of the inspected product." (67) the conducted investigation indicates that the returned device was not defective.(19) no investigation on the manufacturing process of the products could be performed since no traceability data are available and the products remained implanted.However, based on the investigation findings of the related case (see mfg#: 1640201-2022-00022), we conclude that there was most probably also a visual misappreciation of the length of the products made by the observer and that the implanted products are meeting the dimension specifications as presented in the labelling.A letter will be sent to remind the user that the total graft length printed on the product labels is the minimum usable length.Indeed, according to our procedures and in accordance with the applicable international standard iso 7198, the usable length of vascular grafts is measured when graft is stretched at a medium tension without completely eliminating the embossing rings.

Event Description

See mfg initial reports#: 1640201-2022-00020 and #: 1640201-2022-00021.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: 14801055
• MDR Text Key: 295117744
• Report Number: 1640201-2022-00020
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000242
• UDI-Public: (01)00384401000242
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGW0028-30
• Device Catalogue Number: IGW0028-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose