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

Model Number	IGKUT0007-40
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fever (1858); Hypersensitivity/Allergic reaction (1907)
Date of Event	07/04/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that symptoms started one month post-op; the date of the event was arbitrarily set to (b)(6) 2014.Device is not accessible for testing as it is still 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.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.
Event or Problem Description
Since one month post-implantation of the graft on (b)(6) 2014, 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 was implanted on (b)(6) 2016 (see medical device report 1640201-2018-00031).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 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 ULTRATHIN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8184306
• Report Number: 1640201-2018-00030
• Device Sequence Number: 16648181
• Product Code: DSY
• UDI-Device Identifier: 00384401001263
• UDI-Public: 00384401001263
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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: 03/31/2019
• Device Model Number: IGKUT0007-40
• Device Catalogue Number: IGKUT0007-40
• Device Lot Number: 14D10
• 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