BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 16583339 · Received March 21, 2023

    Report

    Report Number
    2029214-2023-00514
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    September 29, 2015
    Report Date
    March 21, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    VEGA, R. A., BRZEZICKI, G., REAVEY-CANTWELL, J. F. DELAYED COLLAPSE OF A PIPELINE EMBOLIZATION DEVICE. OPERATIVE NEUROSURGERY. 2016. 12:83¿88. DOI: 10.1227/NEU.0000000000001043 SUMMARY: THE PIPELINE EMBOLIZATION DEVICE (PED) IS A TREATMENT MODALITY FOR WIDE-NECK COMPLEX INTRACRANIAL ANEURYSMS. THERE HAVE BEEN RECENT REPORTS FOR THE USE OF PEDS IN DISSECTING PSEUDOANEURYSMS OF THE CERVICAL CAROTID ARTERIES. THE USE OF THIS FLOW DIVERSION TECHNOLOGY HAS EMERGED AS A PROMISING ALTERNATIVE; HOWEVER, THERE ARE VARIOUS RISKS AND COMPLICATIONS THAT ONE SHOULD BE AWARE OF. TO REPORT A RARE POSTOPERATIVE COMPLICATION, IDENTIFIED DURING FOLLOW-UP, IN A PATIENT INITIALLY TREATED FOR AN INTERNAL CAROTID ARTERY DISSECTION WITH MULTIPLE OVERLAPPING PEDS. METHODS: A 53-YEAR-OLD MALE WITH UNREMARKABLE HISTORY PRESENTED WITH ACUTE HORNER¿S SYNDROME, AND IMAGING FINDINGS REVEALING INTERNAL CAROTID ARTERY DISSECTION AND PSEUDOANEURYSM WITH SIGNIFICANT FLOW-LIMITING STENOSIS. HE UNDERWENT TREATMENT WITH A PED. AT 3 MONTHS POST-OPERATION, A CEREBRAL ANGIOGRAM DEMONSTRATED THAT ONE OF HIS PIPELINE STENTS IN THE POSTERIOR CAVERNOUS SEGMENT HAD COLLAPSED AT ITS CENTRAL PORTION. FLOW WAS PRESERVED AROUND THE OUTSIDE OF THE COLLAPSED DEVICE. WE PERFORMED 4 ROUNDS OF BALLOON ANGIOPLASTY WITH MODEST, BUT NOT COMPLETE, RE-EXPANSION OF THE STENT. THE PATIENT HAS BEEN DOING WELL IN THE POSTOPERATIVE PERIOD WITH NO COMPLICATIONS. THE PED¿S ROLE IN THE MANAGEMENT OF ANEURYSMS AND OTHER INTRA- AND EXTRA -CRANIAL VASCULAR PATHOLOGIES CONTINUES TO EXPAND, AND NEW COMPLICATIONS ARE BOUND TO BE DISCOVERED, SIMILAR TO OUR CASE. AS THE USE OF THESE DEVICES BECOMES ROUTINE AND WIDESPREAD, THE FREQUENCY OF THESE COMPLICATIONS WILL INCREASE. THE MANAGEMENT OF UNFORESEEN C OMPLICATIONS OF PEDS, SUCH AS A COLLAPSED STENT, WILL NEED TO BE DETERMINED ON AN INDIVIDUAL BASIS. REPORTED EVENTS: THE PATIENT HAD RETURNED TO THE CLINIC 3 MONTHS LATER FOR FOLLOWUP. DURING THAT TIME, THE PATIENT¿S PRIOR SYMPTOMS, WHICH INCLUDED HEADACHE, EARACHE, AND JAW PAIN, HAD ALL SIGNIFICANTLY IMPROVED. HOWEVER, THE PATIENT DID CONTINUE TO HAVE SOME HEADACHES DAILY, WHICH WERE CONTROLLED BY IBUPROFEN. HE HAD ALSO BEEN STARTED ON PYRIDOSTIGMINE FOR HIS OCULAR MYASTHENIA. ON PHYSICAL EXAMINATION, THE PATIENT CONTINUED TO HAVE OPTHALMOPLEGIA AND PTOSIS (RIGHT GREATER THAN LEFT), BUT HAD RESTORATION OF PUPIL SYMMETRY. A COMPUTED TOMOGRAPHY ANGIOGRAM OBTAINED DURING THIS VISIT DEMONSTRATED FOCAL CRITICAL COLLAPSE OF HIS PED IN THE INTRACRANIAL PORTION, WITH MAINTAINED FLOW AROUND THE COLLAPSED SEGMENT. THE PATIENT WAS SCHEDULED FOR BALLOON ANGIOPLASTY 2 WEEKS LATER WITH THE INTENT TO RE-EXPAND THE COLLAPSED SEGMENT. ANGIOGRAPHY CONFIRMED FOCAL COLLAPSE OF THE PED IN THE POSTERIOR CAVERNOUS SEGMENT COMPARED TO THE ORIGINAL PLACEMENT. A MAVERICK BALLOON (BOSTON SCIENTIFIC) WAS INTRODUCED FOR 2 ROUNDS OF BALLOON ANGIOPLASTY. WE THEN REMOVED THE MAVERICK BALLOON TO INTRODUCE A GATEWAY BALLOON AND PERFORMED AN ADDITIONAL 2 ROUNDS OF ANGIOPLASTY. THE COLLAPSED PORTION WENT FROM A TOTAL OF 0.2 MM TO 2 MM. IT WAS NOT FULLY EXPANDED; HOWEVER, IT WAS APPROXIMATELY 10 TIMES LARGER THAN IT WAS PREVIOUSLY. AT THIS TIME, THE FINAL ANTERIOR-POSTERIOR AND LATERAL ANGIOGRAPHY DEMONSTRATED IMPROVEMENT IN THE DIAMETER OF THE STENT AND NO ADVERSE CONSEQUENCES WITH PRESERVATION OF ALL SURROUNDING VASCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18201 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention