MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	IGW0028-15
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device not available for evaluation.
Event or Problem Description
We were asked to provide the product traceability to support an investigation by national competent authority for a patient complaint issue.The only information we know is that the patient sued the hospital after his hospital stay.However we do not know the nature of the complaint and whether our product is involved in an adverse event in the patient.In addition, we know that the national competent authority requested traceability from all manufacturers whose products were involved in the surgical therapeutic process.
Additional Manufacturer Narrative
Corrected data: b2: outcomes attributed to adverse event changed from "other serious (important medical events)" to "death".H1: the type of event was changed from serious injury to death.H6: patient code was changed from 2692 to 1802 death".Initial awareness date: 2019/11/08 instead of 2019/11/10.On june 5th, 2020, the getinge representative provided the designated complaint unit (dcu) information regarding complaint: (b)(4):¿patient died within six months after discharge after surgery¿.It was determined on (b)(6) 2020 that corrections were required regarding the information that was originally captured in initial mfg report number.The getinge representative was aware of this information on november 8th, 2019; however, failed to inform the dcu team with this corrected information provided june 5th, 2020.
Event or Problem Description
Complaint#: (b)(4).

• Brand Name: INTERGARD WOVEN STRAIGHT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9416145
• Report Number: 1640201-2019-00088
• Device Sequence Number: 16756956
• Product Code: DSY
• UDI-Device Identifier: 00384401000235
• UDI-Public: 00384401000235
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: IGW0028-15
• Device Catalogue Number: IGW0028-15
• Device Lot Number: 15L05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2019
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 06/10/2020
• 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: Death; Other