ALBOGRAFT POLYESTER VASCULAR GRAFT
Received Oct 18, 2024 · Event occurred Sep 10, 2024
Report 1220948-2024-00206 · MDR key 20480394
Device
Product problems
- No Apparent Adverse Event
- Difficult or Delayed Separation
- No Apparent Adverse Event
- Difficult or Delayed Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED. THE REPORT WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED GRAFT FAILURE OR CAUSE OF RE-INTERVENTION ON THE GRAFT. AS A RESULT, THE EXACT FAILURE COULD NOT BE INVESTIGATED. THE REPORT OF THE SUPPORT SPIRAL BEING DIFFICULT TO REMOVE DURING RE-INTERVENTION COULD NOT BE CONFIRMED AND DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE PATIENT HEALTH OR REASON OF RE-INTERVENTION. IT IS POSSIBLE THAT THE DIFFICULTY TO REMOVE THE SPIRAL IS DUE TO SURGICAL TECHNIQUE, OR DUE TO AN ERROR IN THE MANUFACTURING PROCESS WHERE THE GRAFT WAS EXPOSED TO TOO MUCH HEAT/TOO LONG OF A DURATION OF HEATING RESULTING IN THE SUPPORT SPIRAL BOND STRENGTH BEING TOO HIGH. THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2024 FOR RE-INTERVENTION ON GRAFT FOR SUSPECTED GRAFT FAILURE. HOWEVER, THE EXACT REASON FOR RE-INTERVENTION IS UNKNOWN. THE GRAFT WAS IMPLANTED ON (B)(6) 2024. THE SURGEON WHO PERFORMED THE ORIGINAL PROCEDURE DID NOT REPORT ANY ISSUES, BUT THE SURGEON WHO INTERVENED REPORTED, THAT THE RINGS ARE DIFFICULT TO REMOVE AND DURING REMOVAL OF THE RINGS THE GRAFT TEARS. NO INJURY WAS REPORTED TO THE PATIENT.