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

Model Number IGW0028-30

Device Problem Defective Device (2588)

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

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22b24.A deeper investigation regarding the traceability has been performed by the qa supervisor.It concluded that the product inversion hypothesis can be excluded.The device history records review concluded that there was no non-conformance / planned deviation in relation with the event reported.The involved device will be returned to intervascular for examination.A visual inspection by the qa department will be performed.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

It was reported to intervascular (complaint (b)(4)) that during a previous surgery, it was observed that the length of two grafts (model igw0028-30) were noticeably shorter than 30 cm.After the operation, due to this event, the hospital stocks were checked and it was observed that a graft of the same reference (igw0028-30) , in stock was also shorter than 30 cm.Two mdrs have been submitted regarding the two first grafts implanted (complaint (b)(4)).

Event Description

See mfg initial report #1640201-2022-00022 complaint (b)(4).

Manufacturer Narrative

(10/213) the involved product was returned to intervascular for examination.It was inspected by the quality assurance (qa) supervisor for an evaluation.His observations are as follows: "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 indicated that the returned device was not defective.Please note that, as per the instructions-for-use, the total graft length printed on the product labels is the minimum usable length.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.

• 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: 14801078
• MDR Text Key: 301190205
• Report Number: 1640201-2022-00022
• 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: 07/25/2022

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: IGW0028-30
• Device Catalogue Number: IGW0028-30
• Device Lot Number: 22B24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose