HEMASHIELD PLATINUM WOVEN AORTIC ARCH 4B
Received Feb 24, 2023 · Event occurred Jan 21, 2023
Report 1640201-2023-00005 · MDR key 16434023
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M00202175926P0Catalog number
M00202175926P0
Lot number
22F01
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Prefer Not To Disclose
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
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).
Description of Event or Problem
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.