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

Model Number IGK1809

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

(3331/213).A review of the complaint device history records indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating and textile records.Moreover, the review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications (< 5 ml/cm²/min).(4109/213) the review of historical data indicated that no other similar complaint was reported for the same lot number.(11/3233) a retention sample coated on the same day and under the same conditions as the involved device was identified.It will undergo water permeability testing.(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

The product is used in the operation of an abdominal aortic aneurysm.When blood flow was resumed after anastomosis of the central part, blood leakage occurred from the entire artificial blood vessel.Remove the anastomosis and place an artificial blood vessel made by another company and finish the procedure.

Manufacturer Narrative

Corrected data : block h6 : method code "(11) testing of device from same lot, retained by manufacturer" was corrected to "(4102) testing of device from other lot, retained by manufacturer" additional information : (4102/213) one retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.Not return as of today (11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint reference (b)(4).

Manufacturer Narrative

(10/213) the involved device was returned to an external and independent laboratory for examination.As part of their conclusion they mention: "no defects in the textile structure were observed which could explain the excessive permeability noticed during the implantation." the laboratory report was sent to our corporate medical officer to have his final comments.His observations concerning the case are as follows: "unfortunately the bleeding details are very limited however the surgeon opted to use a different graft to complete the procedure.There is no information regarding patient¿s preexisting conditions and anticoagulation regimen.Both could have played an important role in the event.Based on the observations contained in the lab report, it appears that the graft has no textile defects and that the macroscopic analysis does not show any aspect that could justify the bleeding observed.The fact that the bleeding was diffuse let me believe that it was more comparable to what we call ¿oozing¿ or ¿sweating¿ of the graft which is expected at de-clamping however it is only speculative at this point." (4315) the cause of the event remains unknown.(67) however, the conducted investigation, which included all available information and the testing we performed, suggests that the device was not defective at the time of manufacturing.(22) blood leakage is a foreseeable side-effect as indicated in the product instructions-for-use, and may be related to several causes including the preexisting condition of the patient and pre- or intra-operative anti-coagulation regimen.

Event Description

Complaint#: (b)(4).

• Brand Name: INTERGARD KNITTED
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9166156
• MDR Text Key: 161786348
• Report Number: 1640201-2019-00078
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000495
• UDI-Public: 00384401000495
• Combination Product (y/n): N
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2022
• Device Model Number: IGK1809
• Device Catalogue Number: IGK1809
• Device Lot Number: 17C23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 10/16/2019; 01/20/2020
• Supplement Dates FDA Received: 11/08/2019; 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention