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

Model Number	HGK0010-100
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intervascular sas (manufacturer) is submitting the report on behalf of maquet cardiovascular, llc (importer), according to the exemption e2017024.(4117) device is not accessible for testing as it remained implanted in the patient.(3331/213) 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).(11/3233) a retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified and will undergo water permeability testing.(4109/213) the review of post-marketing historical data indicated that only one similar complaint was reported for the same lot number.The conducted investigation suggested that the device was not defective.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The case was a zone zero thoracic endovascular aortic repair (tevar).The graft was used to allow for an axillary bypass for access purposes.Patient was heparinized for procedure.Blood was streaming from graft like a waterfall with significant blood loss.The graft was wrapped with thrombogenic material to control the bleeding.Patient was finally stabilized and is recovering in hospital.
Additional Manufacturer Narrative
(11/213) two retention samples from same lot and coated on the same period (one and two days later) and under the same conditions as the involved device underwent water permeability testing.The test results indicated values well within product specifications (< 5 ml/cm²/min).(67) no conclusion can be drawn since the product is not available for investigation.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.(24) please note that, as per the product instructions for use, the use of knitted vascular grafts as a conduit for cannulation is not an approved indication.Indeed, hemagard knitted vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.

• Brand Name: HEMAGARD 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: 8509888
• Report Number: 1640201-2019-00023
• Device Sequence Number: 11171233
• Product Code: DSY
• UDI-Device Identifier: 00384401015093
• UDI-Public: 00384401015093
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 06/30/2020
• Device Model Number: HGK0010-100
• Device Catalogue Number: HGK0010-100
• Device Lot Number: 15G02
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/16/2019
• Device Age: 4 YR
• Initial Date Received by Manufacturer: 03/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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