INTEGRITY RX

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: ANNEX D CODES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

NO UNIQUE DEVICE IDENTIFIER / LOT NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. CITATION: AUTHORS: YIYANG XU,1 WEI YANG,1 XINWEI LI,1 XUN WANG,1 DIHAO PAN,2 ZHENPENG YUAN,1 LEI HAN,3 KAIYUAN HUANG,4 ZHENWEI DING,5 ZIHENG WU,1 CHENYANG QIU,1 AND XIAOHUI WANG JOURNAL NAME: ELSEVIER YEAR: 2025 TITLE OF ARTICLE: ENDOVASCULAR TREATMENT AND HYBRID SURGERY FOR EXTRACRANIAL INTERNAL CAROTID ARTERY ANEURYSMS LITERATURE REFERENCE: HTTPS://DOI.ORG/10.1016/J.AVSG.2025.02.022 DATE OF ARTICLE PUBLISH HAS BEEN USED FOR THE EVENT DATE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

A JOURNAL ARTICLE WAS SUBMITTED FOR REVIEW TITLED 'ENDOVASCULAR TREATMENT AND HYBRID SURGERY FOR EXTRACRANIAL INTERNAL CAROTID ARTERY ANEURYSMS'. IN A CASE REPORT REVIEWED IN THIS ARTICLE, A PATIENT PRESENTED WITH A MINOR STROKE. PREOPERATIVE COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) SHOWED AN ANEURYSM WITH DISSECTION IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THE DISTAL END OF THE ANEURYSM WAS NEAR THE SKULL BASE. AFTER THE EMPLOYMENT OF A 5X50 MM NON-MEDTRONIC COVERED STENT, THE ANGIOGRAPHY SHOWED A DISTAL ENDOLEAK. THEREFORE, TWO MEDTRONIC INTEGRITY BARE METAL STENTS (ONE 4X18MM AND ONE 4X15MM) WERE DEPLOYED, AND COILS WERE USED TO EMBOLIZE THE SAC. ANGIOGRAPHY WAS REPEATED AND CONFIRMED THAT THE ANEURYSM WAS EXCLUDED WITH NO ENDOLEAK. TWELVE MONTHS AFTER SURGERY, THE PATIENT SUFFERED A MINOR STROKE, PRESENTING WITH RIGHT LIMB WEAKNESS AND PARALYSIS, AS WELL AS IMPAIRED SPEECH. THE CTA INDICATED A SEVERE IN-STENT STENOSIS (70%). THE PATIENT WAS READMITTED TO HOSPITAL FOR BALLOON DILATATION/ANGIOPLASTY, AND AFTER A 10-DAY HOSPITALIZATION, THE CEREBRAL INFARCTION SYMPTOMS WERE RELIEVED. POSTOPERATIVE ANGIOGRAPHY SHOWED UNOBSTRUCTED BLOOD FLOW IN THE STENT.