HEMASHIELD PLATINUM WOVEN AORTIC ARCH 4B
Received Mar 3, 2022 · Event occurred Feb 7, 2022
Report 1640201-2022-00006 · MDR key 13658022
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M00202175928P0Catalog number
M00202175928P0
Lot number
21A27
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
THE INVOLVED DEVICE WAS RETURNED TO AN INTERVASCULAR FOR EXAMINATION. A VISUAL INSPECTION BY THE QA DEPARTMENT IS PENDING. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NONCONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. 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 THAT: " PROFESSOR (B)(6) OF THORACIC SURGERY, (B)(6) MEDICAL CENTER, (B)(6) HOSPITAL WHILE PREPARING FOR SURGERY, STAINS WERE FOUND ON THE GRAFT, SO IT WAS NOT USED." NO ADVERSE EVENT WAS REPORTED, THE SURGERY WAS NOT DELAYED. COMPLAINT #(B)(4).
Additional Manufacturer Narrative
(10/213) A VISUAL INSPECTION OF THE INVOLVED PRODUCT WAS PERFORMED BY THE QUALITY ASSURANCE (QA) MANAGER ON 17-MARCH-2022. HIS CONCLUSION IS AS FOLLOWS: THE PRODUCT HAS SLIGHTLY MORE YELLOW AREAS ON THE OUTSIDE OF THE DENTURE. THIS IS COLLAGEN THAT HAS YELLOWED OVER TIME. NOTE THAT AT THE TIME OF QC, THE COLLAGEN IS WHITE/TRANSLUCENT AS A REMINDER, THE PRODUCTS ARE RATHER WHITE WHEN THEY LEAVE OUR PRODUCTION LINES AND TURN YELLOW WITH STERILIZATION AND TIME. THE PRODUCTS AT THE END OF THEIR EXPIRATION DATE ARE OF A STRONGER YELLOW COLOR WITHOUT IMPACT ON THE PRODUCT PERFORMANCE. I SUGGEST THAT THE PRODUCT BE REVIEWED BY THE QUALITY CONTROL (QC) CFM2 TEAM TO ASSESS THE COMPLIANCE OF THE PRODUCT. IN MY OPINION, THERE IS NO EXCESS THICKNESS. THE INVOLVED PRODUCT WAS VISUALLY INSPECTED ON 22-MARCH-2022 BY A QC TECHNICIAN. HIS CONCLUSION IS AS FOLLOWS: THERE IS NOTHING WRONG WITH IT, THE COLLAGEN DOES NOT GO BEYOND THE CRIMPS AND THERE ARE NO BIG CLUMPS. (67) THE CONDUCTED INVESTIGATION CONCLUDED THAT THE PRODUCT WAS NOT DEFECTIVE. PLEASE NOTE THAT THE COLOR OF HEMASHIELD PRODUCTS CHANGES OVER TIME. THE PRODUCTS ARE RATHER WHITE WHEN THEY LEAVE THE MANUFACTURING LINES AND TURN YELLOW WITH STERILIZATION AND OVER TIME. PRODUCTS APPROACHING THE END OF THEIR SHELF LIFE ARE A DEEPER YELLOW COLOR, WITH NO IMPACT ON PRODUCT PERFORMANCE.
Description of Event or Problem
COMPLAINT (B)(4).