MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN AORTIC ARCH 4B; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175926P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22f01.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular that while preparing for total arch replacement surgery, discoloration was found as the collagen melted in the product.The operation was completed with another product of the same model stored at the hospital.There was no harm or effect on the patient.Complaint (b)(4).
Event or Problem Description
Complaint #(b)(4).
Additional Manufacturer Narrative
(10/213) the involved device was returned to intervascular for examination.A visual inspection was performed by a quality control (qc) technician and the quality assurance supervisor, they concluded that, at the time of qc the product was in compliance with the specifications.(67) the conducted investigation concludes that the returned product was conform to the specifications.

• Brand Name: HEMASHIELD PLATINUM WOVEN AORTIC ARCH 4B
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 16434023
• Report Number: 1640201-2023-00005
• Device Sequence Number: 7401162
• Product Code: MAL
• UDI-Device Identifier: 00384401018643
• UDI-Public: (01)00384401018643
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00202175926P0
• Device Catalogue Number: M00202175926P0
• Device Lot Number: 22F01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose