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

Model Number IGW0028-15

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Type  Death  

Manufacturer Narrative

Device not available for evaluation.

Event 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.

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 Description

Complaint#: (b)(4).

• Brand Name: INTERGARD WOVEN STRAIGHT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9416145
• MDR Text Key: 170219297
• Report Number: 1640201-2019-00088
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000235
• UDI-Public: 00384401000235
• Combination Product (y/n): N
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/10/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other