BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 7474448 · Received April 30, 2018

    Report

    Report Number
    1226348-2018-00574
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    December 31, 2016
    Report Date
    April 10, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). THE LITERATURE ARTICLE WAS FOUND DURING A RECENT POST-MARKET SURVEILLANCE REVIEW (PMS) OF THIS DEVICE. THE CITATION IS AS FOLLOWS: HIROHATA, M., SAKAMOTO, R., ABE, T., MORIOKA, H. (2016). USEFULNESS OF STENT ASSISTED ANEURYSMAL EMBOLIZATION FOR THE TREATMENT FOR UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSM. NEURORADIOLOGY, 58 (1), PP. S1-S75. DOI: 10.1007/S00234-016-1734-6. THIS MDR REPORT IS BEING SUBMITTED FOR ONE PATIENT WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBER PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. COMPLAINT CONCLUSION: AS REPORTED IN A LITERATURE ARTICLE BY HIROHATA, M., SAKAMOTO, R., ABE, T., MORIOKA, H., ENTITLED ¿USEFULNESS OF STENT ASSISTED ANEURYSMAL EMBOLIZATION FOR THE TREATMENT OF UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSM¿, A PERIOPERATIVE ASYMPTOMATIC CEREBELLAR INFARCTION OCCURRED IN ONE PATIENT. DURING THE ONE-YEAR FOLLOW-UP VISIT, ONE PATIENT SHOWED MILD RECANALIZATION ON DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). ALL PATIENTS HAD MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AT HOSPITAL DISCHARGE. THERE WAS NO DEVICE SPECIFIC INFORMATION PROVIDED IN THE ARTICLE, INCLUDING DEVICE CATALOG AND LOT NUMBER. THE OBJECTIVE OF THE STUDY WAS TO ANALYZE THE USEFULNESS OF STENT-ASSISTED COIL EMBOLIZATION IN UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS. BETWEEN 2002 AND 2006, 18 PATIENTS (14 MALES, MEAN AGE: 51.4), WITH UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS WERE TREATED WITH STENT-ASSISTED COIL EMBOLIZATION. INDICATIONS FOR SURGERY WERE ANEURYSMAL GROWTH WITHIN FOLLOW-UP OR ANEURYSMS LARGER THAN 10MM. INITIAL SYMPTOMS WERE OCCIPITAL HEADACHE IN EIGHT, ASYMPTOMATIC IN SEVEN, BRAINSTEM INFARCTION IN TWO, AND LOWER CRANIAL NERVE PALSY IN ONE PATIENT. ADDITIONAL IN-STENT BALLOON REMODELING TECHNIQUE WAS USED IN 16 PATIENTS. ALL PROCEDURES WERE CONSIDERED SUCCESSFUL. NEUROFORM STENTS WERE USED IN NINE PATIENTS, ENTERPRISE IN SEVEN, LVIS JR IN TWO, AND UNSPECIFIED CORONARY STENT IN TWO. IT IS NOT POSSIBLE TO DETERMINE IF THE PATIENTS WHO EXPERIENCED ADVERSE EVENTS ACTUALLY RECEIVED ENTERPRISE STENTS; HOWEVER, TO TAKE A CONSERVATIVE APPROACH, THESE EVENTS WILL BE CONSIDERED AS BEING ASSOCIATED WITH THE ENTERPRISE STENT. THE STUDY CONCLUDED THAT STENT-ASSISTED COIL EMBOLIZATION OF UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS IS SAFE AND FEASIBLE TREATMENT. ALTHOUGH FOLLOW-UP PERIODS WERE SHORT, ANEURYSM RECANALIZATION WAS RARE. NO FURTHER INFORMATION WAS PROVIDED. THE ENTERPRISE STENTS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE STERILE LOT NUMBERS ARE NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. CEREBRAL INFARCTION AND ANEURYSM RECANALIZATION ARE KNOWN POTENTIAL COMPLICATIONS THAT CAN OCCUR WITH THE ENTERPRISE STENT AND WITH STENT-ASSISTED COILING. DURING INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH ACCESSORY ARTERIES TO TREAT THE TARGET LESION. THE PHYSICAL MANIPULATION OF THE ARTERIES MAY RESULT IN EMBOLIZATION OF DEBRIS FROM THE INTIMAL LAYERS OF THESE ARTERIES. STUDIES HAVE DEMONSTRATED THAT OUTCOMES OF COIL EMBOLIZATION HAVE PROVED MORE FAVORABLE WITH (VERSUS WITHOUT) STENT ASSISTANCE. STENTING CAN REDUCE THE INCIDENCE OF RECANALIZATION BY ALLOWING GREATER PACKING DENSITY SINCE THE DEVICE HELPS TO HOLD THE COILS INSIDE THE ANEURYSM IN WIDE-NECKED ANEURYSMS. THE ROOT CAUSE OF THE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED BASED ON THE MINIMAL INFORMATION PROVIDED; HOWEVER, IT IS POSSIBLE THAT PATIENT, PHARMACOLOGICAL, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. ANEURYSM RECANALIZATION CAN BE RELATED TO ANEURYSM NECK WIDTH/ANGLE AND COIL PACKING DENSITY. ALTHOUGH NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE ENTERPRISE STENTS AND THE REPORTED EVENTS, THERE IS NO INDICATION THAT THE DEVICES DID NOT PERFORM AS INTENDED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED IN A LITERATURE ARTICLE BY HIROHATA, M., SAKAMOTO, R., ABE, T., MORIOKA, H., ENTITLED ¿USEFULNESS OF STENT ASSISTED ANEURYSMAL EMBOLIZATION FOR THE TREATMENT OF UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSM¿, A PERIOPERATIVE ASYMPTOMATIC CEREBELLAR INFARCTION OCCURRED IN ONE PATIENT. DURING THE ONE-YEAR FOLLOW-UP VISIT, ONE PATIENT SHOWED MILD RECANALIZATION ON DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). ALL PATIENTS HAD MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AT HOSPITAL DISCHARGE. THERE WAS NO DEVICE SPECIFIC INFORMATION PROVIDED IN THE ARTICLE, INCLUDING DEVICE CATALOG AND LOT NUMBER. THE OBJECTIVE OF THE STUDY WAS TO ANALYZE THE USEFULNESS OF STENT-ASSISTED COIL EMBOLIZATION IN UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS. BETWEEN 2002 AND 2006, 18 PATIENTS (14 MALES, MEAN AGE: 51.4), WITH UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS WERE TREATED WITH STENT-ASSISTED COIL EMBOLIZATION. INDICATIONS FOR SURGERY WERE ANEURYSMAL GROWTH WITHIN FOLLOW-UP OR ANEURYSMS LARGER THAN 10MM. INITIAL SYMPTOMS WERE OCCIPITAL HEADACHE IN EIGHT, ASYMPTOMATIC IN SEVEN, BRAINSTEM INFARCTION IN TWO, AND LOWER CRANIAL NERVE PALSY IN ONE PATIENT. ADDITIONAL IN-STENT BALLOON REMODELING TECHNIQUE WAS USED IN 16 PATIENTS. ALL PROCEDURES WERE CONSIDERED SUCCESSFUL. NEUROFORM STENTS WERE USED IN NINE PATIENTS, ENTERPRISE IN SEVEN, LVIS JR IN TWO, AND UNSPECIFIED CORONARY STENT IN TWO. IT IS NOT POSSIBLE TO DETERMINE IF THE PATIENTS WHO EXPERIENCED ADVERSE EVENTS ACTUALLY RECEIVED ENTERPRISE STENTS; HOWEVER, TO TAKE A CONSERVATIVE APPROACH, THESE EVENTS WILL BE CONSIDERED AS BEING ASSOCIATED WITH THE ENTERPRISE STENT. THE STUDY CONCLUDED THAT STENT-ASSISTED COIL EMBOLIZATION OF UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS IS SAFE AND FEASIBLE TREATMENT. ALTHOUGH FOLLOW-UP PERIODS WERE SHORT, ANEURYSM RECANALIZATION WAS RARE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314930 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R