BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX

    MDR report key: 12560665 · Received October 1, 2021

    Report

    Report Number
    9612164-2021-03769
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    November 18, 2020
    Report Date
    December 2, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ANNEX B, ANNEX C, ANNEX D CODES ADDED PROCEDURAL IMAGES AND DATA IN THE ARTICLE PROVIDED THE BASIS OF THE ANALYSIS. IMAGES CONFIRM THE STENTING OF THE RPA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: A CASE SERIES OF THREE PATIENTS WITH UNILATERAL DISCONNECTED PULMONARY ARTERY SUPPLIED BY AN IPSILATERAL PATENT DUCTUS ARTERIOSUS: NEONATAL DUCTAL STENTING AS PALLIATION TO PRESERVE PULMONARY ARTERIAL PATENCY AUTHORS: ANDREW B. HO, TONY P. SALMON, INES HRIBERNIK, NICHOLAS HAYES, JOHN D. THOMSON, JAMES R. BENTHAM JOURNAL: EUROPEAN HEART JOURNAL - CASE REPORTS YEAR: 2020 REFERENCE: DOI:10.1093/EHJCR/YTAA422. DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CASE 2: PATIENT PRESENTED WITH DYSPNOEA ON DAY 2 OF LIFE. AN ECHOCARDIOGRAM DEMONSTRATED A RIGHT PULMONARY ARTERY (RPA) ORIGINATING FROM THE BASE OF THE INNOMINATE ARTERY OF A LEFT-SIDED AORTIC ARCH. THERE WAS A MODERATE-SIZED ATRIAL SEPTAL DEFECT (ASD) SHUNTING LEFT TO RIGHT, AND A DUCTUS FROM THE USUAL SITE CONNECTED TO THE LEFT PULMONARY ARTERY (LPA). THE LPA AROSE NORMALLY FROM THE MAIN PULMONARY ARTERY (MPA) OFF A NORMAL RIGHT VENTRICLE. DIURETICS WERE STARTED, BUT OVER THE SUBSEQUENT WEEKS, PATIENT STRUGGLED WITH POOR WEIGHT GAIN AND ONGOING DYSPNOEA. AT EARLY FOLLOW-UP, NO FLOW WAS SEEN IN THE RPA ON ECHOCARDIOGRAPHY AND A PROSTAGLANDIN INFUSION COMMENCED. CARDIAC CT CONFIRMED THE VESSEL HAD DISCONNECTED AND THE LEFT DUCTUS HAD ALSO CLOSED. IT WAS DECIDED TO PROCEED TO TRANS-CATHETER STENTING OF THE OCCLUDED RIGHT-SIDED DUCT. ANGIOGRAPHY DEMONSTRATED A SMALL AMPULLA AT THE ORIGIN OF THE INNOMINATE ARTERY BUT NO FLOW INTO THE RPA. THE RIGHT-SIDED DUCTUS WAS CROSSED AND STENTED WITH A 3.5X12 MM AND A 3X8 MM MEDTRONIC INTEGRITY BARE-METAL CORONARY STENTS. ALTHOUGH INITIALLY EXTUBATED, WITHIN HOURS PATIENT DETERIORATED WITH A MARKED FALL IN MIXED VENOUS SATURATIONS AND SEVERE RIGHT-SIDED CHEST X-RAY CHANGES REQUIRING REINTUBATION AND A MILRINONE INFUSION. OVER THE COMING DAYS PATIENT EXPERIENCED SIGNIFICANT SHORT-TERM HEMODYNAMIC DETERIORATION. ECHOCARDIOGRAPHY DEMONSTRATED DILATATION OF THE RIGHT VENTRICLE WITH EVIDENCE OF HIGH RIGHT VENTRICULAR (AND THUS LPA) PRESSURES. THERE WAS GENEROUS FLOW DOWN THE STENT INTO THE RIGHT LUNG WITH DIASTOLIC FLOW REVERSAL IN THE ARCH. FLOW ACROSS THE ATRIAL SEPTAL DEFECT (ASD) WAS SIGNIFICANT WITH A LARGE LEFT-TO-RIGHT SHUNT. CHEST X-RAY CHANGES RESOLVED BUT THE PATIENT FAILED TO EXTUBATE, AND WITH A DETERIORATING CLINICAL STATE, SURGICAL ANASTOMOSIS OF THE ABERRANT RPA TO THE MPA WITH FENESTRATED ASD CLOSURE WAS PERFORMED 8 DAYS AFTER CATHETER INTERVENTION USING AN AUTOLOGOUS PERICARDIAL PATCH TO AUGMENT THE VESSEL. PRE-DISCHARGE ECHOCARDIOGRAPHY DEMONSTRATED A NORMALLY SIZED RIGHT VENTRICLE WITH NORMAL PULMONARY ARTERY PRESSURES. ONE YEAR POST-INTERVENTION, NO FURTHER INTERVENTIONS HAVE BEEN REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463220 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention