2031527-2016-00231

Report

Report Number: 2031527-2016-00231
Event Type: Injury
Date Received: May 19, 2017
PMA / PMN Number: P040002
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

AT THE COMPLETION OF THE COMPLAINT INVESTIGATION, BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE REPORTED EVENT WAS CONFIRMED. ALTHOUGH THE PLASTIC FRAGMENTS WERE NOT RECEIVED A REVIEW OF THE INNER LUMEN CONFIRMED THE MISSING MATERIAL. THE REVIEW OF THE MANUFACTURING LOT CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. A ROOT CAUSE INVESTIGATION WAS COMPLETED AND DETERMINED THE PLASTIC FRAGMENTS WERE FROM DAMAGE TO AN INTRODUCER SHEATH BY AN UNCOVERED COIL OF THE BIFURCATED STENT WHEN PASSED THROUGH THE INTRODUCER SHEATH. CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE DURING THE MANUFACTURING PROCESS WHICH INCLUDE IMPROVED LOADING OF THE STENTS AND MAKING SURE THE END COILS ARE COVERED. THERE HAVE ALSO BEEN ADDITIONAL VISUAL INSPECTIONS ADDED, PRIOR TO FINAL RELEASE OF THE PRODUCTS. FURTHERMORE DESIGN IMPROVEMENTS HAVE BEEN INCORPORATED INTO THE NEXT GENERATION DEVICE, AFX2, AND TO DATE WE HAVE NOT SEEN THIS FAILURE MODE OCCUR IN THIS ITERATION OF THE DESIGN. DEVICE CODES, METHOD CODES, RESULT CODES, AND CONCLUSION CODES HAVE BEEN UPDATED.

Description of Event or Problem · 1

PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION ON (B)(6) 2016. AT THE COMPLETION OF THE INITIAL IMPLANT PROCEDURE THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND FOUND THREE PLASTIC FIBERS IN THE RIGHT IPSILATERAL GROIN. THE PHYSICIAN REMOVED THE FIBERS AND CLOSED THE ACCESS SITES. PATIENT IS STABLE.

Patients

Seq	Age	Sex	Outcome	Treatment
1