MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD KNITTED; VASCULAR POLYESTER GRAFT

Model Number	IGK1608
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fever (1858); Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that symptoms started one month post-implantation of the first graft, the date of the event related to this second graft is therefore unknown (missing value).(b)(4).
Event or Problem Description
Since one month post-implantation of a first graft on (b)(6) 2014 (see medical device report 1640201-2018-00030), the patient has had an extremely complex clinical presentation with recurrent fever of unknown origin, recurrent pyelonephritis due to ureteral compression with placement of dj stents and discovery of graft/ureter conflict.A second graft (the subject of this report) was implanted on (b)(6) 2016 and symptoms continued.The patient has been the subject of numerous investigations.A "contact vasculitis" to dacron grafts was diagnosed.All investigations made by the hospital are described in the attached file.The affected grafts were not explanted from the patient yet.
Additional Manufacturer Narrative
(4315) the hospital performed an allergy workup on the patient with samples of our grafts.All tests remained negative.The hospital concluded that, to date, there is no evidence of specific sensitization but a range of arguments in favor of an abnormal reaction of the patient to the grafts.The cause of the patient's reaction remains undetermined.However, the outcome of the investigation suggests that the involved grafts were not defective at the time of manufacturing and that an allergy to bovine collagen or polyester can be reasonably excluded.

• Brand Name: INTERGARD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8184307
• Report Number: 1640201-2018-00031
• Device Sequence Number: 2639904
• Product Code: DSY
• UDI-Device Identifier: 00384401000488
• UDI-Public: 00384401000488
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 08/31/2020
• Device Model Number: IGK1608
• Device Catalogue Number: IGK1608
• Device Lot Number: 15J17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 05/20/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 68 YR