BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6517543 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00517
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    March 18, 2016
    Report Date
    October 17, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KOO, H. ET AL. (2017). FRACTURE AND MIGRATION OF A RETAINED WIRE INTO THE THORACIC CAVITY AFTER ENDOVASCULAR NEUROINTERVENTION: REPORT OF 2 CASES. JOURNAL OF NEUROSURGERY, 126(2), 354-359. DOI:10.3171/2015.12.JNS152381 THE PIPELINE BRAID REMAINS IMPLANTED IN THE PATIENT AND THE RETRIEVED SEGMENTS OF THE PUSHWIRE WERE DISCARDED BY THE CUSTOMER. THE DEVICE WAS NOT RETURNED; THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PIPELINE PUSHWIRE SEPARATION DURING A PROCEDURE. THE ARTICLE STATES THAT A PATIENT UNDERWENT PIPELINE TREATMENT OF AN UNRUPTURED ANEURYSM IN THE LEFT, CAVERNOUS INTERNAL CAROTID ARTERY (ICA). THE PATIENT HAD PRESENTED WITH CHRONIC HEADACHES AND INTERMITTENT DIPLOPIA. THE ANEURYSM HAD A MAXIMUM DIAMETER WAS 2MM AND NECK SIZE OF 8MM. THE PARENT VESSEL DIAMETER WAS 3.9MM PROXIMAL AND 3.8MM DISTAL. THE PATIENT WAS PREMEDICATED WITH ASPIRIN AND CLOPIDOGREL FOR FIVE DAYS. DURING THE PROCEDURE, THE PIPELINE DEVICE WAS DEPLOYED ACROSS THE ANEURYSM NECK WITHOUT DIFFICULTY, EXTENDING FROM THE OPHTHALMIC ICA TO THE POSTERIOR GENU OF THE CAVERNOUS ICA. AFTER FULL DEPLOYMENT, THE MICROCATHETER WAS ADVANCED TO OVER THE PUSHWIRE THROUGH THE DEPLOYED PIPELINE LUMEN. THE ARTICLE STATES THAT THE PUSHWIRE WAS ROTATED CLOCKWISE SEVERAL TIMES TO ¿SAFELY CAPTURE LOOSE COILS, AS IS INSTRUCTED IN THE USER MANUAL.¿ WHILE ROTATING THE PUSHWIRE, THE ARTICLE STATES THAT THERE WAS A SUDDEN, UNUSUAL LIMITATION OF THE TIP OF THE LEAD WIRE, WHICH HAD INITIALLY BEEN FREELY ROTATED. THE TIP DID NOT MOVE IN RESPONSE TO THE PUSH-PULL MANIPULATION OF THE PUSHWIRE TOGETHER WITH THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE WIRE. SUBSEQUENT CONTROL ANGIOGRAM DEMONSTRATED OCCLUSION OF THE POSTERIOR COMMUNICATING ARTERY (PCOA) FROM THE ORIGIN. IT WAS OBSERVED THAT THE LEAD WIRE TIP WAS LOCATED AT THE ORIGIN OF THE OCCLUDED VESSEL. THE PHYSICIANS INITIALLY SUSPECTED THAT SEVERE VASOSPASM HAD HELD THE WIRE TIGHTLY. AFTER WAITING MORE THAN HOUR, THE WIRE WAS NOT RELEASED. THE PROCEDURE WAS HALTED, LEAVING THE PUSH WIRE WITHIN THE VESSEL. THE PATIENT RETURNED THE FOLLOWING DAY; THE WIRE WAS STILL STUCK AND RETRIEVAL WAS UNSUCCESSFUL. THE PUSH WIRE REMAINED IN THE PATIENT. THE GUIDEWIRE WAS TRANSECTED AT THE LEVEL OF THE FEMORAL ARTERY PUNCTURE POINT AND ANCHORED TO THE SUBCUTANEOUS FASCIA LAYER WITH A MONOFILAMENT SUTURE. POST-OPERATIVE NEUROLOGICAL EXAM SHOWED THAT THE PATIENT HAD MILD RIGHT MOTOR WEAKNESS. DIFFUSION MRI SHOWED ACUTE INFARCTION IN THE GENU PORTION OF THE LEFT INTERNAL CAPSULE. A FEW DAYS LATER, THE PATIENT HAD IMPROVED AND WAS DISCHARGED WITHOUT RESIDUAL SYMPTOMS. ONE MONTH LATER, FOLLOW-UP CHEST AND SKULL RADIOGRAPHY WAS PERFORMED AND DID NOT SHOW ANY CHANGE COMPARED WITH THE IMMEDIATE POSTOPERATIVE RADIOGRAPHY FINDINGS. ABOUT 6 WEEKS LATER, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF GENERAL MALAISE, INTERMITTENT PLEURITIC PAIN, AND SEVERAL EPISODES OF BLOODY OOZING FROM THE FEMORAL PUNCTURE SITE. THE WOUND WAS SWOLLEN WITH GRANULOMA FORMATION AND THE PUNCTURE HOLE REMAINED OPEN, SUGGESTING NONHEALING OF THE PUNCTURE SITE. SKULL RADIOGRAPHS DID NOT SHOW ANY CHANGE IN EITHER THE PED OR RETAINED WIRE. HOWEVER, THE CHEST RADIOGRAPH SHOWED A BLUNTING OF THE RIGHT COSTOPHRENIC ANGLE AND A VERY THIN, CURVILINEAR STRUCTURE FROM THE RIGHT PARATRACHEAL AREA TO THE RIGHT LOWER LATERAL CHEST WALL. SUBSEQUENT CHEST CT SCANS SHOWED A LONG METALLIC WIRE PIERCING THE RIGHT LUNG FROM THE MEDIAL ASPECT OF THE RIGHT UPPER LOBE TO THE LATERAL ASPECT OF THE RIGHT LOWER LOBE. THIS 20-CM-LONG PIECE OF WIRE WAS IDENTIFIED AS THE MIDDLE SEGMENT OF THE FRACTURED WIRE THAT HAD MIGRATED FROM THE LEFT COMMON CAROTID ARTERY INTO THE RIGHT THORACIC CAVITY, PIERCING THE LUNG. ABOUT 10 CM OF THE DISTAL SEGMENT OF THE FRACTURED WIRE REMAINED IN THE LEFT ICA, AND THE PROXIMAL PART OF THE WIRE RETAINED IN THE AORTA WAS ATTACHED TO THE TAGGING SITE AT THE COMMON FEMORAL ARTERY. THE PHYSICIANS BELIEVE THAT PERSISTENT FOREIGN BODY REACTION AT THE TAGGING SITE PREVENTED HEALING OF THE PUNCTURE SITE. THE PATIENT UNDERWENT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) FOR REMOVAL OF THE WIRE LOCATED IN THE RIGHT THORACIC CAVITY. THE THORACOSCOPIC IMAGE SHOWED A LONG WIRE FRAGMENT PUNCTURING THE VISCERAL PLEURA OF THE RIGHT LUNG AND RESULTING IN REGIONAL HEMORRHAGE AND ADHESION TO THE PARIETAL PLEURA. THE WIRE WAS REMOVED WITHOUT DIFFICULTY AND WITHOUT LEAVING ANY SIGNIFICANT DEFECT IN THE PLEURA. THE RETRIEVED SEGMENT OF THE WIRE WAS ABOUT 22 CM LONG AND ITS ENDS WERE SERRATED, SUGGESTING FRACTURE AT BOTH ENDS. AFTER VATS, THE PROXIMAL PART OF THE RETAINED WIRE WAS REMOVED AFTER SURGICAL EXPOSURE OF THE FEMORAL PUNCTURE SITE. AN APPROXIMATELY A 55-CM-LONG PROXIMAL PART OF THE WIRE FRAGMENT WAS REMOVED. THE PATIENT IMPROVED AND WAS THEN DISCHARGED FROM THE HOSPITAL AND PLACED ON A PLANNED 6-MONTH DUAL ANTIPLATELET REGIMEN. THE RETRIEVED SEGMENTS WERE DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298245 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77450-20 A021689

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention