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

Model Number	IGK2010
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional 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.Specifically, no anomaly was evidenced in the collagen coating 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).The review of post marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Device evaluated by manufacturer? not returned to manufacturer.
Event or Problem Description
During the operation of a thoracoabdominal aortic aneurysm, an hemashield graft was used.The complaint intergard graft was anastomosed on the peripheral side of the hemashield graft.Then, when the clamp was released, blood leakage was observed from the entire intergard graft.After neutralizing with protamine, blood leakage gradually stopped.The product is not returned because it is implanted in the patient's body.
Additional Manufacturer Narrative
(11/213) one retention sample from the same lot, 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).(67) no conclusion can be drawn since the product remained implanted.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.The case was reviewed by our corporate medical officer who provided his assessment as follows: "from the description of the event, it appears that the graft had a more significant oozing or blushing throughout the graft than expected by the operator.However, after the use of protamine which is customary for this operation the bleeding stopped and the graft remained implanted.The increased blushing from the graft could be associate to the preoperative coagulative condition of the patient.The latter could be influenced by a variety of different drugs and disorders.In general, an increase propensity to bleed would not be considered as unusual in this patient population.Ultimately it is impossible to make a full assessment and determine the real causes of the unusual bleeding as the graft could not be analyzed.However it is very likely that the pre-operative conditions had a significant impact on the event described.".(22) please note that blood leakage is a foreseeable side-effect as indicated in the instructions for use.

• Brand Name: INTERGARD KNITTED
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 8699979
• Report Number: 1640201-2019-00032
• Device Sequence Number: 1968201
• Product Code: DSY
• UDI-Device Identifier: 00384401000501
• UDI-Public: 00384401000501
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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
• Operator of Device: No Information
• Device Expiration Date: 07/31/2020
• Device Model Number: IGK2010
• Device Catalogue Number: IGK2010
• Device Lot Number: 15H06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention