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

Model Number	HGK0008-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) a review of the device history records, indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests, and no anomaly was found.Specifically, no anomaly was evidenced in the textile records which indicate that the textile run was released following compliant physical and mechanical tests results.(b)(4) a visual inspection of the returned graft was performed by the quality assurance supervisor.The product was returned in a biohazard package.The graft was cut lengthwise.It does not show any structural defect.An additional visual inspection was also performed by the textile expert who confirmed that there is no anomaly on the textile structure.He noticed that the cut does not seem usual.In addition, the case was reviewed by our corporate medical officer.His clinical opinion is the following: "the information provided and especially the unclear description of the event don't allow a comprehensive assessment.However, reviewing the pictures provided, it appears that the incision of the graft to conform it to the anastomotic site it is unusually long.The anastomosis performed in this kind of procedure is end-to-side.End of the graft (beveled 30-45 degrees) to the side of the native vessel, the iliac artery in this case.Also it is unclear how the graft could have "broken or cracked".The integrity analysis shows not defects.The procedural delay to substitute the graft increased the patient's operative risk however he/she did not experience any adverse clinical consequence." (b)(4) no conclusion can be drawn.However, the investigation performed would tend to indicate that the device was not defective at the time of manufacturing.
Event or Problem Description
During an ilio-iliac bypass surgery performed on (b)(6) 2017, it was reported that the graft was cut off to adapt to the anatomical conditions.When inserting into the anastomosis, the graft cracked.Another hgk0008-20 graft was used to complete the surgery.The surgery was prolonged by 10 min and ended regularly.It was reported that the current status of the patient was good.

• 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: 7052968
• Report Number: 1640201-2017-00036
• Device Sequence Number: 18849296
• Product Code: DSY
• UDI-Device Identifier: 00384401014133
• UDI-Public: 00384401014133
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 06/30/2022
• Device Model Number: HGK0008-20
• Device Catalogue Number: HGK0008-20
• Device Lot Number: 17G06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/22/2017
• 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