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

Model Number	HGK1809
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the complaint device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.(b)(4).One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.(b)(4).A remaining fragment of the involved product has been sent to an outside laboratory for macroscopic and scanning electron microscopy analysis.The investigation is still on-going.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
During an extraanatomical bypass surgery performed on (b)(6) 2016 for an abdominal aortic aneurysma, it was reported a bleeding through the graft.The bleeding occurred during sewing the anastomosis and stopped by itself after waiting nearly half an hour.The graft remained implanted.No adverse consequence for the patient has been reported.
Additional Manufacturer Narrative
The remaining fragment analysis performed by an outside laboratory showed no textile abnormality such as tear, hole, filament rupture or sectioning, loss of the textile cohesion.The ultrastructural analysis corroborated the macroscopic observations.The presence of collagen coating was also confirmed.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.

• Brand Name: HEMAGARD KNITTED GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5720234
• Report Number: 1640201-2016-00016
• Device Sequence Number: 18853893
• Product Code: DSY
• UDI-Device Identifier: 00384401014393
• UDI-Public: 00384401014393
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2016

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: 12/31/2019
• Device Model Number: HGK1809
• Device Catalogue Number: HGK1809
• Device Lot Number: 15A29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 07/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBIOTICS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 90