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

Model Number IGW0026-30

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

It was reported that the involved product is available for investigation, it should be returned to intervascular for examination.A visual inspection by the qa department is pending.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21e20.The device history records review is pending the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

It was reported to intervascular that the circulator noticed the yellow spot on the graft before it was on the sterile field.The tyvek lid of the product was sealed.There was another graft, so the surgery was not delayed at all.Complaint # (b)(4).

Manufacturer Narrative

(3331/213) the device history records review concluded that there was no non-conformance / planned deviation in relation with the event reported.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

See mfg initial report #1640201-2022-00014.Complaint #(b)(4).

Event Description

See mfg reports #1640201-2022-00014 complaint #(b)(4).

Manufacturer Narrative

(10/213) the involved device was returned to intervascular to be inspected by the qa supervisor.He confirmed that a yellow stain (about 2 x 1 cm) was present on the device.However, the stain is related to an excess of collagen.Excess collagen is a cosmetic defect and is routinely accepted according to the limits of acceptability defined in product specifications.In this case, the collagen stain has no excess thickness, so the product is in compliance for use.(67) the conducted investigation indicates that the product was not defective.

• 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: 14240397
• MDR Text Key: 291239976
• Report Number: 1640201-2022-00014
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 038440100022
• UDI-Public: (01)038440100022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2022

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: IGW0026-30
• Device Catalogue Number: IGW0026-30
• Device Lot Number: 21E20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 05/04/2022; 07/27/2022
• Supplement Dates FDA Received: 05/20/2022; 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose