BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 16330863 · Received February 9, 2023

    Report

    Report Number
    3002808486-2023-00041
    Event Type
    Injury
    Date Received
    February 9, 2023
    Report Date
    March 7, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE SUBJECT OF THE COMPLAINT WAS A 55-YEAR-OLD MAN HAVING A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) FOR A STANFORD TYPE B DISSECTION. OF PRE-EXISTING DISEASES, HE HAD HYPERTENSION AND POLYCYSTIC KIDNEY DISEASE. THE PATIENT WAS INITIALLY TREATED WITH MEDICAL THERAPY FOR 6 MONTHS, BUT SYMPTOMS (PAIN) WERE UNRESPONSIVE AND GRADUALLY INCREASED WHY HE SOUGHT MEDICAL CARE. AT ADMISSION ECHOCARDIOGRAPHY SHOWED LEFT VENTRICULAR HYPERTROPHY. CONTRAST-ENHANCED CT SHOWED A STANFORD TYPE B DISSECTION WITH ENTRY 25 MM DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA), EXTENDING DISTALLY UP TO THE AORTOILIAC BIFURCATION. NO EVIDENCE OF A DISTAL RE-ENTRY TEAR. AN ENDOVASCULAR PROCEDURE WAS PERFORMED. A LUNDERQUIST (LES) WIRE GUIDE (COMPLAINT DEVICE) WAS PLACED IN THE ASCENDING AORTA. A VALIANT STENT GRAFT (GRAFT FROM ANOTHER MANUFACTURER) WAS DEPLOYED DISTAL TO THE LEFT COMMON CAROTID ARTERY COVERING THE ORIGIN OF THE LSA. JUST AFTER THE DEPLOYMENT OF THE STENT GRAFT, THE SYSTOLIC BLOOD PRESSURE OF THE LOWER LIMBS DROPPED SUDDENLY TO 30 MMHG WITH A NON-PULSATILE FLOW, WHEREAS THE SYSTOLIC BLOOD PRESSURE OF THE UPPER LIMBS WAS 150 MMHG. THE AUTHORS THOUGHT THAT THE STENT GRAFT HAD BEEN DEPLOYED FROM THE TRUE LUMEN INTO THE FALSE LUMEN CAUSING THE COMPRESSION OF THE TRUE LUMEN DISTALLY. A CHECK ANGIOGRAM FROM THE BRACHIAL ARTERY PIGTAIL SHOWED NO FLOW DISTAL TO THE STENT GRAFT INTO THE TRUE LUMEN CONFIRMING OBLITERATION OF THE TRUE LUMEN. AN EMERGENCY PERCUTANEOUS APPROACH WAS CHOSEN AS A BAILOUT WHERE THE DISSECTION FLAP WAS PUNCTURED, AND AN ADDITIONAL VALIANT STENT GRAFT (FROM ANOTHER MANUFACTURER) WAS DEPLOYED OVER A SECOND LUNDERQUIST GUIDEWIRE. THE SECOND STENT GRAFT WAS DEPLOYED FROM THE PROXIMAL END OF THE PREVIOUS STENT GRAFT (IN THE FALSE LUMEN) TO 5 CM DISTAL TO THE PREVIOUS STENT GRAFT. THE DISTAL END OF THE SECOND STENT GRAFT WAS IN THE TRUE LUMEN. FLOW IN THE LOWER LIMB NORMALIZED. AORTOGRAPHY SHOWED FLOW PRESERVATION IN THE ARCH VESSELS AND PATENT STENT GRAFTS AND GOOD DISTAL PERFUSION OF THE RENAL AND INFERIOR MESENTERIC ARTERIES AND THE BILATERAL ILIAC ARTERIES. THE POSTOPERATIVE COURSE WAS UNEVENTFUL AND 3 MONTHS FOLLOW-UP SHOWED PATENT AND WELL APPOSED STENT GRAFTS WITH COMPLETE OBLITERATION OF THE FALSE LUMEN AND NO EVIDENCE OF ENDOLEAK. THE PATIENT HAS BEEN HEMODYNAMICALLY STABLE AND UNDER REGULAR FOLLOW-UPS FOR THE LAST 3 YEARS (CASE-REPORT FROM MAY 2021). REGARDING THE EVENT THE AUTHORS STATES THAT THE MOST PLAUSIBLE EXPLANATION COULD BE THAT THE GUIDEWIRE TRAVERSED FROM THE TRUE LUMEN TO THE FALSE LUMEN THROUGH AN UNRECOGNIZED DISTAL TEAR OF THE DISSECTION AND REENTERED THE TRUE LUMEN THROUGH THE PROXIMAL DISSECTION ENTRY TEAR. THE WIRE GUIDE WAS NOT RETURNED FOR INVESTIGATION AND FROM THE PROVIDED INFORMATION IT IS NOT POSSIBLE TO ESTABLISH AN EXACT CAUSE OF THE EVENT (DEPLOYMENT OF STENT GRAFT IN FALSE LUMEN). ON CT NO DISTAL RE-ENTRY TEAR WAS DESCRIBED BUT AS THE AUTHORS IMPLY IT COULD HAVE BEEN UNRECOGNIZED. THERE IS NO FURTHER INFORMATION ON WHETHER A RETROSPECTIVE LOOK ON THAT PRE- PROCEDURE CT HAD CHANGED THAT. SPECULATIVELY AN INTRAPROCEDURAL PERFORATION OF THE FLAP BY E.G., THE LES WIRE GUIDE CANNOT BE RULED OUT, BUT THE ARTICLE DOES NOT SEEM TO HAVE ANY IMPLICATION ON THIS. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE TYPE OF DEVICE WAS MANUFACTURED TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK LUNDERQUIST GUIDEWIRE. SIMILAR TO DEVICE UNDER PMA/510(K) K220137. E2402: HEMODYNAMIC COLLAPSE AND VISCERAL MALPERFUSION. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: THE PATIENT PRESENTED WITH SYMPTOMS OF RETROSTERNAL CHEST PAIN RADIATING TO THE BACK INTERMITTENTLY FOR THE PRECEDING 6 MONTHS. HIS SYMPTOMS WERE UNRESPONSIVE TO MEDICAL THERAPY AND GRADUALLY INCREASED IN SEVERITY, FOR WHICH HE SOUGHT MEDICAL CARE. THE PATIENT¿S VITAL SIGNS AT ADMISSION WERE BLOOD PRESSURE OF 180/100 MM HG AND HEART RATE OF 96 BPM. HE HAD A HISTORY OF POORLY CONTROLLED BLOOD PRESSURE FOR THE LAST 6 MONTHS DESPITE BEING ON 3 ANTIHYPERTENSIVE DRUGS IN ADEQUATE DOSAGES INADVERTENT DEPLOYMENT OF STENT GRAFTS INTO THE FALSE LUMEN DURING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). THEY PRESENT A CASE OF ACCIDENTAL STENT-GRAFT DEPLOYMENT FROM THE TRUE LUMEN INTO THE FALSE LUMEN DURING TEVAR, RESULTING IN HEMODYNAMIC COLLAPSE AND VISCERAL MALPERFUSION. THEY PERFORMED A BAILOUT USING THE BROCKENBROUGH NEEDLE TO CREATE NEW ACCESS FROM THE TRUE LUMEN TO THE FALSE LUMEN AND IMPLANTED ANOTHER OVERLAPPING STENT GRAFT. PATIENT OUTCOME: THE PATIENT WAS DISCHARGED 1 WEEK AFTER THE PROCEDURE. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. REPEAT CT ANGIOGRAPHY AFTER 3 MONTHS SHOWED PATENT AND WELL APPOSED STENT GRAFTS WITH COMPLETE OBLITERATION OF THE FALSE LUMEN AND NO EVIDENCE OF ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461899 DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention