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

Model Number HGK0008-100

Device Problem Disconnection (1171)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

During an axillo femoral bypass performed on (b)(6) 2015, bleeding occurred through the graft.The bleeding stopped by itself after about half an hour without any additional medication or surgical intervention.The event has been communicated to the designated complaint handling unit on (b)(6) 2015.

Manufacturer Narrative

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.Additional information is being sought.A follow-up will be sent upon conclusion of the investigation.

Manufacturer Narrative

One remaining fragment of the complaint device has been sent to an outside laboratory for macroscopic and scanning electron microscopy (sem) evaluation.The sem analysis showed no significant abnormality such as tear, extensive filament rupture, sectioning, loss of the textile cohesion or hole, neither macroscopically nor ultrastructurally.The presence of collagen was 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.

Manufacturer Narrative

(b)(4) a review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specificaly, 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)) additionnal information is being seeked.A follow-up will be sent upon conclusion of the investigation.

• Brand Name: HEMAGARD KNITTED GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 1370 5; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 1370 5; FR 13705
• Manufacturer Contact: pascal de framond ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208134
• MDR Report Key: 4804962
• MDR Text Key: 5892079
• Report Number: 1640201-2015-00020
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2015

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: Other
• Device Expiration Date: 06/30/2019
• Device Model Number: HGK0008-100
• Device Catalogue Number: HGK0008-100
• Device Lot Number: 14G10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/08/2015; 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEPARIN; ANTIBIOTICS; ANTICOAGULANTS
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 88