BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 21089572 · Received January 7, 2025

    Report

    Report Number
    9612164-2025-00097
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    October 22, 2024
    Report Date
    February 11, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL ARTICLE: COVERED STENT IMPLANTATION FOR CALCIFIED NODULE TO PHYSICALLY HINDER ITS PROTRUSION CAUSING RESTENOSIS: A CASE REPORT JOURNAL: CARDIOVASCULAR DIAGNOSIS AND THERAPY YEAR: 2024 REF: HTTPS://DX.DOI.ORG/10.21037/CDT-24-216 B3: DATE OF PUBLICATION 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 · 0

    ADDITIONAL INFORMATION: LOT NUMBER PROVIDED CORRECTION: AUTHORS: SATOSHI KITAHARA YU KATAOKA, MIHO TADA, HIROYOSHI KAWAMOTO, <(>&<)> YUSUKE FUJINO. 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 · 0

    A CASE STUDY WAS SUBMITTED FOR REVIEW TITLED "COVERED STENT IMPLANTATION FOR CALCIFIED NODULE TO PHYSICALLY HINDER ITS PROTRUSION CAUSING RESTENOSIS: A CASE REPORT". THE STUDY DESCRIBES A CASE WHO RECEIVED THE IMPLANTATION OF ONE COVERED STENT DUE TO CORONARY ARTERY PERFORATION AFTER STENT IMPLANTATION AT CORONARY LESION EXHIBITING A CALCIFIED NODULE (CN). THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PROLONGED CHEST PAIN. INITIAL BLOOD PRESSURE WAS 163/127 MMHG AND HEART RATE WAS 82 BEATS PER MINUTE AT THE EMERGENCY DEPARTMENT. THERE WAS NO REMARKABLE PHYSICAL EXAMINATION INCLUDING CARDIAC MURMURS AND RESPIRATORY SOUNDS. THE ELECTROCARDIOGRAM SHOWED ATRIAL FIBRILLATION AND ST SEGMENT ELEVATION IN LEADS I, II, AVL AND V4¿6. IN ADDITION, ECHOCARDIOGRAPHY SHOWED A REDUCED WALL MOTION AT POSTEROLATERAL REGION. ON LABORATORY DATA, CREATININE WAS 1.02 MG/DL, HEMOGLOBIN A1C WAS 5.9%, LOW DENSITY LIPOPROTEIN CHOLESTEROL WAS 112 MG/DL, AND NO EVIDENCE OF ELEVATION OF CARDIAC ENZYME AT THE PRESENTATION. THE PATIENT WAS DIAGNOSED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. EMERGENT CORONARY ANGIOGRAPHY WAS PERFORMED. CORONARY ANGIOGRAM REVEALED SEVERE STENOSIS AT THE MIDDLE SEGMENT OF THE RIGHT CORONARY ARTERY (RCA), MODERATE STENOSIS AT MIDDLE SEGMENT OF LEFT ANTERIOR DESCENDING ARTERY AND MIDDLE SEGMENT OF LEFT CIRCUMFLEX ARTERY. PRIMARY PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED UNDER THE GUIDANCE OF NON-MEDTRONIC INTRAVASCULAR ULTRASOUND (IVUS) IMAGING. IVUS IMAGING PRIOR TO THE PCI REVEALED A PROTRUDING SHAPE OF CALCIFICATION WITH A IRREGULAR SURFACE WHICH SUGGESTED THE PRESENCE OF TYPE 1 ECCENTRIC CN IN THE CULPRIT LESION. THE DEVICE DELIVERY WAS DIFFICULT DUE TO THE CORONARY ARTERY TORTUOSITY AND MODERATE STENOSIS AT THE PROXIMAL SEGMENT OF THE RCA. ONE 4.0 MM × 15 MM RESOLUTE ONYX DRUG ELUTING STENT DES WAS IMPLANTED AT THE PROXIMAL SEGMENT OF THE RCA. THEN INTERVENTION WAS CONDUCTED TO THE CULPRIT LESION. FOLLOWING BALLOON ANGIOPLASTY WITH NON-MEDTRONIC 3.0 MM × 15 MM NONCOMPLIANT BALLOON CATHETER AT 14 ATM, O NE 4.0 MM × 15 MM RESOLUTE ONYX DES WAS IMPLANTED AT 12 ATM. HOWEVER, STENT UNDEREXPANSION WAS OBSERVED BY CORONARY ANGIOGRAPHY AFTER STENT IMPLANTATION. THE POST-DILATATION OF THE IMPLANTED STENT WAS UNDERGONE BY USING THE STENT BALLOON CATHETER AT 16 ATM. AFTER THIS PROCEDURE, THE PATIENT COMPLAINED CHEST PAIN AND THEN THE PATIENTS HEMODYNAMIC STATUS SUDDENLY DETERIORATED. CORONARY ANGIOGRAPHY REVEALED THE OCCURRENCE OF CORONARY ARTERY PERFORATION AT THE SEGMENT RECEIVING DES IMPLANTATION . A NON-MEDTRONIC 4.0 MM × 15 MM NON-COMPLIANT BALLOON WAS USED TO SEAL CORONARY ARTERY PERFORATION SITE AT 10 ATM FOR 120 SECONDS. HOWEVER, CORONARY PERFORATION WAS STILL OBSERVED. AFTER THE INSERTION OF INTRA-AORTIC BALLOON PUMPING CATHETER THE DECISION WAS MADE TO IMPLANT ONE NON-MEDTRONIC 3.5 MM × 15 MM COVERED STENT. THEN, POST-DILATATION OF THE IMPLANTED COVERED STENT WAS UNDERGONE BY USING THE NON-MEDTRONIC 4.0 MM × 8 MM NON-COMPLIANT BALLOON AT 14 ATM. THESE PROCEDURES RESULTED IN SUCCESSFULLY SEALING CORONARY ARTERY PERFORATION SITE. THE IVUS IMAGING AFTER POST DILATATION OF COVERED STENT, DEMONSTRATED OPTIMAL STENT APPOSITION AND STENT EXPANSION. THE STENT WAS DILATED ALMOST TO A REGULAR CIRCLE. BECAUSE OF THE SUCCESSFUL PCI, THE PATIENTS SYMPTOM WAS RECOVERED AND ST SEGMENT ELEVATION AT ELECTROCARDI OGRAM WAS RESOLVED. SEVEN MONTHS AFTER THE PCI, FOLLOW-UP CORONARY ANGIOGRAPHY AND NON-MEDTRONIC OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGING WERE CONDUCTED TO EVALUATE THE RCA. IN-STENT RESTENOSIS (ISR) WAS NOT OBSERVED IN THE PATIENTS RCA. FURTHERMORE, OCT IMAGING ELUCIDATED A SMALL AMOUNT OF NEOINTIMAL PROLIFERATION WITHOUT ANY PROTRUDING FEATURE OF CN THROUGH THE SEGMENT RECEIVING A COVERED STENT. THE PATIENT DID NOT EXPERIENCE ANY CLINICALLY-DRIVEN TARGET LESION REVASCULARIZATION (TLR) OR NO ADVERSE EVENTS FOR 2 YEARS AFTER PCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835261 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND RONYX40015JX 0008677944

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention