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

Model Number IGK0008RS45 - INTERGARD KNITTED RS

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

Device is not accessible for testing as it remained implanted in the patient.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.A retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified.The investigation is ongoing.The review of post-marketing historical data indicated that no other similar complaint was reported for the same product family and the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

According to the reporter: "use interguard on the right a-f bypass.A large amount of blood leaked from the graft after passing through the artificial blood vessel using a sheath type tunneler and releasing the graft after the central anastomosis was terminated and flowing the blood.Blood leakage seemed to ooze from the entire graft, not from the anastomosis, but the amount of bleeding was large and the location could not be specified.If i could not proceed with the procedure and looked at the situation for a while, the blood leak had subsided and the operation continued.After that, the operation was completed without any problems, but there is an opinion that postoperative edema is a concern.This time, the left a-f bypass was also anastomosed with another interguard, but there was no problem with this, so the institution determined that it was not due to the patient's influence.".

Event Description

See initial mdr mfr report # 1640201-2019-00081.

Manufacturer Narrative

Corrected data: blocks d8, d10 , h3 and h6 are corrected.Block d8 was checked as "yes" inadvertently.Block d10 was checked as ¿no¿ because the product was not known as available at the date of the initial report but it was finally returned to the manufacturer.Block h3 was checked as ¿no¿ because the product was not known as available at the date of the initial report but it was finally returned to the manufacturer.Block h6 mentioned 4117 as method code but it is now changed with 10 as the product is now available and sent to an external and independent laboratory for examination.Additional manufacturer narrative: (11/213) one retention sample from same lot and coated on the same day and under the same conditions as the involved device was underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(10/3233) the involved device was sent to an external and independent laboratory for examination.The investigation is ongoing.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

Additional mfg narrative: the case has been reviewed by our corporate medical officer, his assessment is as follows: "the event recorded describes the use of an intergard knitted graft to perform an axillary to femoral artery bypass.The surgeon mentioned significant oozing from the graft after de-clamping following the axillary anastomosis.The bleeding was homogenously distributed across the graft.After few minutes, the oozing stopped and the procedure was completed successfully.The analysis of the specimen received was inconclusive.The hypothesis is that the collagen coating was disrupted by tunneling the graft.This action is necessary and it could require significant force that is transmitted to the graft.In this case, the graft was anastomosed to another intergard product that did not show the same behavior therefore it is assumed that patient's preconditions and coagulation factors did not play a role in the event.No additional information has been provided regarding the patient's recovery." (67) the conducted investigation would tend to indicate that the product was not defective at the time of manufacturing.Please note that, as per instruction for use, care should be taken when handling the graft to avoid damaging the collagen coating.

Event Description

See initial mfr report # 1640201-2019-00081.Complaint #(b)(4).

Event Description

See initial mfr report # 1640201-2019-00081.Complaint #(b)(4).

Manufacturer Narrative

(10/213) the involved device was sent to an external and independent laboratory for examination.Their conclusion are as follows : "this segment probably corresponds to a residual segment of the implanted graft, no macroscopical defects in the textile structure were observed which could explain the excessive permeability noticed during the implantation.Since the segment is completely impregnated with blood the initial permeability of the graft cannot be verified.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

• Brand Name: INTERGARD/HEMAGARD
• 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: 9238789
• MDR Text Key: 178277623
• Report Number: 1640201-2019-00081
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000778
• UDI-Public: 00384401000778
• 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,Followup
• Report Date: 05/20/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: IGK0008RS45 - INTERGARD KNITTED RS
• Device Catalogue Number: IGK0008RS45
• Device Lot Number: 18M27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/21/2019; 02/19/2020; 04/28/2020
• Supplement Dates FDA Received: 12/16/2019; 03/16/2020; 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening