MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR; VASCULAR POLYESTER GRAFT

Model Number	M00202175824P0
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not accessible for testing as it remained 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.These tests include a 100% visual inspection of the graft using a backlit table to reveal the presence of any holes in the textile structure.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
The event occurred during an on-pump surgery without intra-aortic balloon (iab) use.After completing the anastomosis of the graft to the aorta, a hole was identified by the appearance of a blood leak at the junction of the single branch of the graft.It was first mentioned that the surgeon sutured the hole to complete the operation.It was then stated that bleeding was stopped by the application of pressure for about 5 minutes.The graft remained implanted and no remaining fragment is available for investigation.
Additional Manufacturer Narrative
Our medical corporate officer reviewed the case, his assessment is as follows : "the event describes the presence of a minor blood jet at the junction of the single branch to the main graft after declamping of a hemashield platinum woven aortic arch 1 branch.The bleeding was successfully addressed by 5 minutes local compression.The patient's preconditions were not noted.No clinical consequence was recorded.Due to the minimal and focalized bleeding as well as to the method of resolution, the bleeding was possibly due to a minor stretch of the fabric at the anastomotic site.It is impossible to determine if the stretch occurred during manufacturing or it is due to procedural manipulation.The graft remained implanted.".
Additional Manufacturer Narrative
(25) the outcome of the investigation would tend to indicate that the issue was related to a slight stretching of the woven fabric during the sewing step.As a preventive measure, all sewing operators have been made aware of the potential risk of greige stretching during sewing.An update of qc and sewing instructions has been performed.

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8321283
• Report Number: 1640201-2019-00007
• Device Sequence Number: 11101978
• Product Code: MAL
• UDI-Device Identifier: 00384401018551
• UDI-Public: 00384401018551
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2019

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: 07/31/2023
• Device Model Number: M00202175824P0
• Device Catalogue Number: M00202175824P0
• Device Lot Number: 18H01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 10/18/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 10/10/2019; 11/14/2019
• 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