BEAD BLOCK
Report
- Report Number
- 3002124545-2016-00073
- Event Type
- Injury
- Date Received
- December 20, 2016
- Report Date
- December 5, 2016
- Manufacturer
- BIOCOMPATIBLES UK LTD
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
HIGH INSUFFICIENT FIBROID BURDEN INFARCTION [DEVICE INEFFECTIVE]. PERSISTING SYMPTOMS [DEVICE INEFFECTIVE]. MAJOR COMPLICATIONS, SIR CLASS D REQUIRED PROLONGED HOSPITAL STAY > 48H [HOSPITALISATION] SIR CLASS C OCCURRED IN ONE (4% PATIENT) WHO REQUIRED PROLONGED HOSPITAL STAY <48H [HOSPITALISATION]. PAIN. FIBROID INFECTION WITH PURULENT DISCHARGE [INFECTED NEOPLASM]. FIBROID EXPULSION [UTERINE MYOMA EXPULSION]. "SILENT" FIBROID EXPULSION [UTERINE MYOMA EXPULSION.] CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 05-DEC-2016: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A LITERATURE ARTICLE BY DUVNKAK S., ET AL. ENTITLED "UTERINE FIBROID EMBOLIZATION WITH ACRYLAMIDE POLYVINYL MICROSPHERES: PROSPECTIVE 12-MONTH CLINICAL AND MRI FOLLOW-UP" PUBLISHED IN THE ACTA RADIOLOGICA, CONCERNING 26 FEMALE PATIENTS, WITH AN AGE RANGE OF 38 TO 51 YEARS (MEAN AGE 45.1 YEARS). INFORMED CONSENT WAS WAIVED FROM ALL PARTICIPANTS AND THE REGIONAL ETHIC COMMITTEE APPROVED THE STUDY ((B)(6)). THE PATIENTS' MEDICAL HISTORY INCLUDED SYMPTOMATIC UTERINE FIBROIDS. THE DOMINANT SYMPTOMS WERE BLEEDING AND/OR BLEEDING AND BULK-RELATED SYMPTOMS IN 50% OF THE PATIENTS. BULK-RELATED SYMPTOMS AND/OR PAIN WERE THE DOMINANT SYMPTOMS IN 50% OF THE PATIENTS. THE MOST FREQUENT FIBROID LOCALIZATION WAS INTRAMURAL (73%), FOLLOWED BY SUBSEROSAL (5%) AND SUBMUCOSAL (2 %). THIRTY-ONE PERCENT OF THE PATIENTS HAD A SINGLE FIBROID, 46% HAD 2-5 FIBROIDS, AND 23% HAD >5 FIBROIDS. THE MEDIAN BASELINE VOLUME OF THE DOMINANT FIBROIDS WAS 184.8 CM^3 (RANGE, 32-515 CM^3). MEDIAN UTERINE BASELINE VOLUME WAS 496.7 CM^3 (RANGE, 206-2449 CM^3). THE CONCOMITANT MEDICATIONS FOR ALL PATIENTS INCLUDED A SELF-CONTROLLED MORPHINE ANALGESIA PUMP WITH MORPHINE LOADING DOSE OF 2MG AND AN INTERMITTENT DOSE OF 1 MG MORPHINE WITH LOCKOUT INTERVALS OF 10 MIN, FOR AN UNKNOWN INDICATION. PERIORAL MEDICATION AND ANTIEMETIC DRUGS WERE PRESCRIBED IF NEEDED. ON AN UNSPECIFIED DATE, BETWEEN OCT-2013 AND JAN-2015, THE PATIENTS WERE EMBOLIZED WITH BEAD BLOCK (BEAD SIZE 700-900 MICROM, LOT NUMBERS AND EXPIRATION DATES NOT REPORTED) ALONE OR WITH ONE VIAL OF BEAD BLOCK (BEAD SIZE 500-700 MICROM, LOT NUMBERS AND EXPIRATION DATES NOT REPORTED) FOLLOWED BY OTHER VIALS OF BEAD BLOCK (BEAD SIZE 700-900 MICROM, LOT NUMBERS AND EXPIRATION DATES NOT REPORTED), FOR SYMPTOMATIC UTERINE FIBROIDS, UNTIL COMPLETE FLOW-STOP DISTAL TO THE MICRO-CATHETER. EMBOLIZATION ENDPOINT WAS DEFINED AS COMPLETE FLOW STOP IN THE TRANSVERSAL (HORIZONTAL) PART OF THE UTERINE ARTERY. FIVE MINUTES AFTER THE EMBOLIZATION, THE CONTINUOUS ACHIEVEMENT OF THE ENDPOINT WAS CONFIRMED BY FLUSHING CONTRAST. IN THE CASE OF INCOMPLETE FLOW STOP, SUPPLEMENTARY EMBOLIZATION WAS PERFORMED. FINALLY, ABDOMINAL AORTOGRAPHY WAS PERFORMED TO DISCLOSE POSSIBLE FIBROID SUPPLY FROM THE OVARIAN ARTERIES. AT DISCRETION WITH THE PATIENT, IT WAS DECIDED WHETHER OR NOT TO PERFORM SUPPLEMENTARY EMBOLIZATION OF THE OVARIAN ARTERY. BEAD BLOCK WAS ADMINISTERED WITH THE USE OF A LOCAL ANAESTHESIA VIA UNILATERAL PERCUTANEOUS TRANS-FEMORAL ACCESS BY THE SAME INTERVENTIONAL RADIOLOGY SPECIALIST. AFTER SELECTIVE CATHETERIZATION OF BOTH INTERNAL ILIAC ARTERIES WITH 5 FR DIAGNOSTIC CATHETERS AND BY USE OF MICROCATHETERS (DIREXION HI-FLO, INNER LUMEN 0,027'', BOSTON SCIENTIFIC, (B)(4)) PLACED IN THE TRANSVERSAL PART OF THE UTERINE ARTERY, EMBOLIZATION WITH BEAD BLOCK MICROSPHERES WAS PERFORMED TILL FLOW-STOP IN ALL CASES. COMPLICATIONS IN THE ENTIRE COHORT OF 26 PATIENTS WERE CLASSIFIED ACCORDING TO THE SOCIETY OF INTERVENTIONAL RADIOLOGY (SIR). TWENTY-TWO OF 26 PATIENTS COMPLETED THE 3-MONTH FOLLOW-UP WITH CONTRAST ENHANCED MAGNETIC RESONANCE IMAGING (MRI). TWENTY OF 26 PATIENTS COMPLETED THE 12-MONTH CONTROL. TWO PATIENTS WITHDREW FROM THE STUDY AFTER HAVING COMPLETED THE 3-MONTH CONTROL. FOUR PATIENTS HAD NO MRI FOLLOW-UP AT ALL, OF WHICH, ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED PERSISTING SYMPTOMS AND ANOTHER FIBROID INFECTION WITH PURULENT DISCHARGE. AS SUCH BOTH PATIENTS UNDERWENT A HYSTERECTOMY APPROXIMATELY 2 MONTHS AFTER UTERINE FIBROID EMBOLIZATION (UFE). THE THIRD PATIENT, ON AN UNKNOWN DATE, EXPERIENCED FIBROID EXPULSION WHICH REQUIRED GYNAECOLOGICAL ASSISTANCE 3 WEEKS AFTER UFE AND FOLLOWING THE EVENT THE PATIENT WITHDREW FROM THE STUDY. THE FOURTH PATIENT REFUSED FURTHER FOLLOW-UP. ON AN UNKNOWN DATE, OF THE 22 PATIENTS, 6 PATIENTS EXPERIENCED FIBROID BURDEN INFARCTION WITH RESIDUAL CONTRAST ENHANCEMENT OF MORE THAN 10%. THREE PATIENTS HAD INSUFFICIENT DOMINANT FIBROID INFARCTION AND THREE PATIENTS HAD INSUFFICIENT NON-DOMINANT FIBROID INFARCTION. THE PATIENT WITH INSUFFICIENT FIBROID INFARCTION ALSO HAD FIBROID SUPPLY FROM THE OVARIAN ARTERY, WHICH MAY EXPLAIN RESIDUAL CONTRAST ENHANCEMENT. THERE WAS NO OTHER MRI OR ANGIOGRAPHIC FINDINGS WHICH COULD EXPLAIN RESIDUAL CONTRAST ENHANCEMENT IN THE OTHER FIVE PATIENTS. IN THESE PATIENTS, HALF OF THE CASES HAD NON-DOMINANT SMALL FIBROID RESIDUAL CONTRAST ENHANCEMENT SUGGESTING THAT FIBROIDS MIGHT GROW AND BECOME SYMPTOMATIC WITHIN THE FOLLOWING 3-5 YEARS. IN ANOTHER HALF OF THE PATIENTS, THE DOMINANT FIBROID HAD RESIDUAL CONTRAST ENHANCEMENT SUGGESTING THAT SYMPTOM RECURRENCE MIGHT OCCUR AFTER A SHORT PERIOD OF TIME, USUALLY WITHIN A FEW YEARS. IN OUR THREE CASES WITH INSUFFICIENT DOMINANT FIBROID INFARCTION, WE HAD NONE WITH SYMPTOM RECURRENCE AT 1-YEAR FOLLOW-UP. ON AN UNKNOWN DATE, 2 PATIENTS EXPERIENCED MAJOR COMPLICATIONS, SIR CLASS D, THAT REQUIRED PROLONGED HOSPITAL STAY >48 H AND MAJOR THERAPY. THE OUTCOME OF THIS EVENT WAS NOT REPORTED. ON AN UNKNOWN DATE, A SIR CLASS C COMPLICATION OCCURRED IN 1 PATIENT WHO REQUIRED PROLONGED HOSPITAL STAY <48 H. THE TREATMENT AND OUTCOME WAS NOT REPORTED. ADDITIONALLY, SIR CLASS B COMPLICATIONS OCCURRED, ON AN UNKNOWN DATE, IN 6 PATIENTS WHO REQUIRED HOSPITAL STAY OVERNIGHT DUE TO PAIN COMPLAINT IN THREE CASES AND "SILENT" FIBROID EXPULSION WITH PROLONGED DISCHARGE AND REQUIRING NO ADDITIONAL INTERVENTION IN THREE CASES. THERE WERE NO CASES WITH REPORTED AMENORRHEA AFTER UFE. THE AUTHORS CONSIDERED THE EVENTS OF HOSPITALIZATION (SIR CLASS D AND C) AS MAJOR COMPLICATIONS. FURTHERMORE, THE AUTHORS CONSIDERED THE EVENT HIGH INSUFFICIENT FIBROID BURDEN INFARCTION AS UNACCEPTABLE. THE AUTHORS COULD NOT EXPLAIN FROM ANATOMICAL OR MORPHOLOGICAL REASON WHY THEY HAD 27% INSUFFICIENT FIBROID BURDEN INFRACTION. THERE WAS NO ADDITIONAL FIBROID SUPPLY FROM THE OTHER ABERRANT VESSELS AND IN ONLY ONE PATIENT FIBROID SUPPLY FROM OVARIAN ARTERY WAS LEFT UNTREATED. A POSSIBLE EXPLANATION FOR THAT IN THE PRESENT STUDY COULD BE THE PHYSICAL PROPERTY OF BEAD BLOCK MICROSPHERES AND PROBABLY MORE DEFORMITY IN SHAPE AFTER DELIVERY. THE AUTHORS DID NOT USE BEAD BLOCK MICROSPHERES MORE IN THEIR DEPARTMENT AFTER THIS STUDY. THE AUTHORS DID NOT PROVIDE A CAUSALITY ASSESSMENT OF THE EVENTS OF PERSISTING SYMPTOMS, HOSPITALISATION (SIR CLASS D AND C), PAIN, FIBROID INFECTION WITH PURULENT DISCHARGE, FIBROID EXPULSION AND "SILENT" FIBROID EXPULSION TO THE USE OF BEAD BLOCK. THE COMPANY ASSESSED ALL THE EVENTS AS SERIOUS (MEDICALLY SIGNIFICANT, HOSPITALIZATION, INTERVENTION REQUIRED). FOLLOW-UP INFORMATION WILL BE REQUESTED. CASE COMMENTS: THE EVENT DEVICE INEFFECTIVE IS CONSIDERED UNLISTED ACCORDING TO THE BEAD BLOCK CURRENT REFERENCE SAFETY INFORMATION, WHEREAS THE EVENTS HOSPITALISATION, INFECTED NEOPLASM AND UTERINE MYOMA EXPULSION ARE LISTED. PAIN IS ALSO CONSIDERED LISTED ACCORDING TO THE BEAD BLOCK CURRENT REFERENCE SAFETY INFORMATION, AND ALTHOUGH ANATOMICALLY UNSTATED, IT WOULD BE LOWER ABDOMINAL IN NATURE HENCE EXPECTED. IN LINE WITH THE ASSESSMENT MADE BY THE REPORTER, AND CONSIDERING THE PLAUSIBLE TEMPORAL SEQUENCE, THE COMPANY CONSIDERED DEVICE INEFFECTIVE RELATED TO THE USE OF BEAD BLOCK. ADDITIONALLY, IN THE ABSENCE OF AN ASSESSMENT MADE BY THE REPORTER, THE COMPANY CONSIDERED HOSPITALISATION, PAIN, INFECTED NEOPLASM AND UTERINE MYOMA EXPULSION RELATED TO THE USE OF BEAD BLOCK, SINCE ITS ROLE CANNOT BE RULED OUT. THERE WAS NO EVIDENCE OF MALFUNCTION. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF BEAD BLOCK. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.
HIGH INSUFFICIENT FIBROID BURDEN INFARCTION [DEVICE INEFFECTIVE], PERSISTING SYMPTOMS [DEVICE INEFFECTIVE], MAJOR COMPLICATIONS, SIR CLASS D REQUIRED PROLONGED HOSPITAL STAY > 48H [HOSPITALISATION], SIR CLASS C OCCURRED IN ONE (4% PATIENT) WHO REQUIRED PROLONGED HOSPITAL STAY <48H [HOSPITALISATION], PAIN [PAIN], FIBROID INFECTION WITH PURULENT DISCHARGE [INFECTED NEOPLASM], FIBROID EXPULSION [UTERINE MYOMA EXPULSION], "SILENT" FIBROID EXPULSION [UTERINE MYOMA EXPULSION]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 05-DEC-2016: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A LITERATURE ARTICLE BY DUVNKAK S., ET AL. ENTITLED "UTERINE FIBROID EMBOLIZATION WITH ACRYLAMIDE POLYVINYL MICROSPHERES: PROSPECTIVE 12-MONTH CLINICAL AND MRI FOLLOW-UP" PUBLISHED IN THE ACTA RADIOLOGICA, CONCERNING 26 FEMALE PATIENTS, WITH AN AGE RANGE OF 38 TO 51 YEARS (MEAN AGE 45.1 YEARS). INFORMED CONSENT WAS WAIVED FROM ALL PARTICIPANTS AND THE REGIONAL ETHIC COMMITTEE APPROVED THE STUDY ((B)(6)). THE PATIENTS' MEDICAL HISTORY INCLUDED SYMPTOMATIC UTERINE FIBROIDS. THE DOMINANT SYMPTOMS WERE BLEEDING AND/OR BLEEDING AND BULK-RELATED SYMPTOMS IN 50% OF THE PATIENTS. BULK-RELATED SYMPTOMS AND/OR PAIN WERE THE DOMINANT SYMPTOMS IN 50% OF THE PATIENTS. THE MOST FREQUENT FIBROID LOCALIZATION WAS INTRAMURAL (73%), FOLLOWED BY SUBSEROSAL (5%) AND SUBMUCOSAL (2 %). THIRTY-ONE PERCENT OF THE PATIENTS HAD A SINGLE FIBROID, 46% HAD 2-5 FIBROIDS, AND 23% HAD >5 FIBROIDS. THE MEDIAN BASELINE VOLUME OF THE DOMINANT FIBROIDS WAS 184.8 CM^3 (RANGE, 32-515 CM^3). MEDIAN UTERINE BASELINE VOLUME WAS 496.7 CM^3 (RANGE, 206-2449 CM^3). THE CONCOMITANT MEDICATIONS FOR ALL PATIENTS INCLUDED A SELF-CONTROLLED MORPHINE ANALGESIA PUMP WITH MORPHINE LOADING DOSE OF 2MG AND AN INTERMITTENT DOSE OF 1 MG MORPHINE WITH LOCKOUT INTERVALS OF 10 MIN, FOR AN UNKNOWN INDICATION. PERIORAL MEDICATION AND ANTIEMETIC DRUGS WERE PRESCRIBED IF NEEDED. ON AN UNSPECIFIED DATE, BETWEEN OCT-2013 AND JAN-2015, THE PATIENTS WERE EMBOLIZED WITH BEAD BLOCK (BEAD SIZE 700-900 MICROM, LOT NUMBERS AND EXPIRATION DATES NOT REPORTED) ALONE OR WITH ONE VIAL OF BEAD BLOCK (BEAD SIZE 500-700 MICROM, LOT NUMBERS AND EXPIRATION DATES NOT REPORTED) FOLLOWED BY OTHER VIALS OF BEAD BLOCK (BEAD SIZE 700-900 MICROM, LOT NUMBERS AND EXPIRATION DATES NOT REPORTED), FOR SYMPTOMATIC UTERINE FIBROIDS, UNTIL COMPLETE FLOW-STOP DISTAL TO THE MICRO-CATHETER. EMBOLIZATION ENDPOINT WAS DEFINED AS COMPLETE FLOW STOP IN THE TRANSVERSAL (HORIZONTAL) PART OF THE UTERINE ARTERY. FIVE MINUTES AFTER THE EMBOLIZATION, THE CONTINUOUS ACHIEVEMENT OF THE ENDPOINT WAS CONFIRMED BY FLUSHING CONTRAST. IN THE CASE OF INCOMPLETE FLOW STOP, SUPPLEMENTARY EMBOLIZATION WAS PERFORMED. FINALLY, ABDOMINAL AORTOGRAPHY WAS PERFORMED TO DISCLOSE POSSIBLE FIBROID SUPPLY FROM THE OVARIAN ARTERIES. AT DISCRETION WITH THE PATIENT, IT WAS DECIDED WHETHER OR NOT TO PERFORM SUPPLEMENTARY EMBOLIZATION OF THE OVARIAN ARTERY. BEAD BLOCK WAS ADMINISTERED WITH THE USE OF A LOCAL ANAESTHESIA VIA UNILATERAL PERCUTANEOUS TRANS-FEMORAL ACCESS BY THE SAME INTERVENTIONAL RADIOLOGY SPECIALIST. AFTER SELECTIVE CATHETERIZATION OF BOTH INTERNAL ILIAC ARTERIES WITH 5 FR DIAGNOSTIC CATHETERS AND BY USE OF MICROCATHETERS (DIREXION HI-FLO, INNER LUMEN 0,027'', BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA) PLACED IN THE TRANSVERSAL PART OF THE UTERINE ARTERY, EMBOLIZATION WITH BEAD BLOCK MICROSPHERES WAS PERFORMED TILL FLOW-STOP IN ALL CASES. COMPLICATIONS IN THE ENTIRE COHORT OF 26 PATIENTS WERE CLASSIFIED ACCORDING TO THE SOCIETY OF INTERVENTIONAL RADIOLOGY (SIR). TWENTY-TWO OF 26 PATIENTS COMPLETED THE 3-MONTH FOLLOW-UP WITH CONTRAST ENHANCED MAGNETIC RESONANCE IMAGING (MRI). TWENTY OF 26 PATIENTS COMPLETED THE 12-MONTH CONTROL. TWO PATIENTS WITHDREW FROM THE STUDY AFTER HAVING COMPLETED THE 3-MONTH CONTROL. FOUR PATIENTS HAD NO MRI FOLLOW-UP AT ALL, OF WHICH, ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED PERSISTING SYMPTOMS AND ANOTHER FIBROID INFECTION WITH PURULENT DISCHARGE. AS SUCH BOTH PATIENTS UNDERWENT A HYSTERECTOMY APPROXIMATELY 2 MONTHS AFTER UTERINE FIBROID EMBOLIZATION (UFE). THE THIRD PATIENT, ON AN UNKNOWN DATE, EXPERIENCED FIBROID EXPULSION WHICH REQUIRED GYNAECOLOGICAL ASSISTANCE 3 WEEKS AFTER UFE AND FOLLOWING THE EVENT THE PATIENT WITHDREW FROM THE STUDY. THE FOURTH PATIENT REFUSED FURTHER FOLLOW-UP. ON AN UNKNOWN DATE, OF THE 22 PATIENTS, 6 PATIENTS EXPERIENCED FIBROID BURDEN INFARCTION WITH RESIDUAL CONTRAST ENHANCEMENT OF MORE THAN 10%. THREE PATIENTS HAD INSUFFICIENT DOMINANT FIBROID INFARCTION AND THREE PATIENTS HAD INSUFFICIENT NON-DOMINANT FIBROID INFARCTION. THE PATIENT WITH INSUFFICIENT FIBROID INFARCTION ALSO HAD FIBROID SUPPLY FROM THE OVARIAN ARTERY, WHICH MAY EXPLAIN RESIDUAL CONTRAST ENHANCEMENT. THERE WAS NO OTHER MRI OR ANGIOGRAPHIC FINDINGS WHICH COULD EXPLAIN RESIDUAL CONTRAST ENHANCEMENT IN THE OTHER FIVE PATIENTS. IN THESE PATIENTS, HALF OF THE CASES HAD NON-DOMINANT SMALL FIBROID RESIDUAL CONTRAST ENHANCEMENT SUGGESTING THAT FIBROIDS MIGHT GROW AND BECOME SYMPTOMATIC WITHIN THE FOLLOWING 3-5 YEARS. IN ANOTHER HALF OF THE PATIENTS, THE DOMINANT FIBROID HAD RESIDUAL CONTRAST ENHANCEMENT SUGGESTING THAT SYMPTOM RECURRENCE MIGHT OCCUR AFTER A SHORT PERIOD OF TIME, USUALLY WITHIN A FEW YEARS. IN OUR THREE CASES WITH INSUFFICIENT DOMINANT FIBROID INFARCTION, WE HAD NONE WITH SYMPTOM RECURRENCE AT 1-YEAR FOLLOW-UP. ON AN UNKNOWN DATE, 2 PATIENTS EXPERIENCED MAJOR COMPLICATIONS, SIR CLASS D, THAT REQUIRED PROLONGED HOSPITAL STAY >48 H AND MAJOR THERAPY. THE OUTCOME OF THIS EVENT WAS NOT REPORTED. ON AN UNKNOWN DATE, A SIR CLASS C COMPLICATION OCCURRED IN 1 PATIENT WHO REQUIRED PROLONGED HOSPITAL STAY <48 H. THE TREATMENT AND OUTCOME WAS NOT REPORTED. ADDITIONALLY, SIR CLASS B COMPLICATIONS OCCURRED, ON AN UNKNOWN DATE, IN 6 PATIENTS WHO REQUIRED HOSPITAL STAY OVERNIGHT DUE TO PAIN COMPLAINT IN THREE CASES AND "SILENT" FIBROID EXPULSION WITH PROLONGED DISCHARGE AND REQUIRING NO ADDITIONAL INTERVENTION IN THREE CASES. THERE WERE NO CASES WITH REPORTED AMENORRHEA AFTER UFE. THE AUTHORS CONSIDERED THE EVENTS OF HOSPITALIZATION (SIR CLASS D AND C) AS MAJOR COMPLICATIONS. FURTHERMORE, THE AUTHORS CONSIDERED THE EVENT HIGH INSUFFICIENT FIBROID BURDEN INFARCTION AS UNACCEPTABLE. THE AUTHORS COULD NOT EXPLAIN FROM ANATOMICAL OR MORPHOLOGICAL REASON WHY THEY HAD 27% INSUFFICIENT FIBROID BURDEN INFRACTION. THERE WAS NO ADDITIONAL FIBROID SUPPLY FROM THE OTHER ABERRANT VESSELS AND IN ONLY ONE PATIENT FIBROID SUPPLY FROM OVARIAN ARTERY WAS LEFT UNTREATED. A POSSIBLE EXPLANATION FOR THAT IN THE PRESENT STUDY COULD BE THE PHYSICAL PROPERTY OF BEAD BLOCK MICROSPHERES AND PROBABLY MORE DEFORMITY IN SHAPE AFTER DELIVERY. THE AUTHORS DID NOT USE BEAD BLOCK MICROSPHERES MORE IN THEIR DEPARTMENT AFTER THIS STUDY. THE AUTHORS DID NOT PROVIDE A CAUSALITY ASSESSMENT OF THE EVENTS OF PERSISTING SYMPTOMS, HOSPITALISATION (SIR CLASS D AND C), PAIN, FIBROID INFECTION WITH PURULENT DISCHARGE, FIBROID EXPULSION AND "SILENT" FIBROID EXPULSION TO THE USE OF BEAD BLOCK. THE COMPANY ASSESSED ALL THE EVENTS AS SERIOUS (MEDICALLY SIGNIFICANT, HOSPITALIZATION, INTERVENTION REQUIRED). FOLLOW-UP INFORMATION WILL BE REQUESTED. FOLLOW-UP INFORMATION RECEIVED ON 15-DEC-2016 FROM THE REPORTING AUTHOR: THE TREATING PHYSICIAN REPORTED THE COMPLICATIONS MENTIONED IN THE ARTICLE HAD NOTHING TO DO WITH BEAD BLOCK AND WERE NOT SEEN AS AN ADVERSE EVENT. THEY WERE UFE PROCEDURE RELATED COMPLICATIONS THAT WERE WELL KNOWN WITHIN UFE TREATMENTS (THE COMPLICATIONS THAT WERE SEEN - HYSTERECTOMY, INFECTION, PAIN). IN ADDITION HE STATED, THAT THESE KIND OF COMPLICATIONS HAVE BEEN SEEN WITH OTHER PARTICLES TOO. NO DEVICE FAILURE HAS BEEN IDENTIFIED AS A RESULT OF THESE ADVERSE EVENTS. IT HAS BEEN ASSESSED THAT NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME AND THE REPORT IS CONSIDERED FINAL. CASE COMMENTS: THE EVENT DEVICE INEFFECTIVE IS CONSIDERED UNLISTED ACCORDING TO THE BEAD BLOCK CURRENT REFERENCE SAFETY INFORMATION, WHEREAS THE EVENTS HOSPITALISATION, INFECTED NEOPLASM AND UTERINE MYOMA EXPULSION ARE LISTED. PAIN IS ALSO CONSIDERED LISTED ACCORDING TO THE BEAD BLOCK CURRENT REFERENCE SAFETY INFORMATION, AND ALTHOUGH ANATOMICALLY UNSTATED, IT WOULD BE LOWER ABDOMINAL IN NATURE HENCE EXPECTED. IN LINE WITH THE ASSESSMENT MADE BY THE REPORTER, AND CONSIDERING THE PLAUSIBLE TEMPORAL SEQUENCE, THE COMPANY CONSIDERED DEVICE INEFFECTIVE RELATED TO THE USE OF BEAD BLOCK. ADDITIONALLY, IN THE ABSENCE OF AN ASSESSMENT MADE BY THE REPORTER, THE COMPANY CONSIDERED HOSPITALISATION, PAIN, INFECTED NEOPLASM AND UTERINE MYOMA EXPULSION RELATED TO THE USE OF BEAD BLOCK, SINCE ITS ROLE CANNOT BE RULED OUT. THERE WAS NO EVIDENCE OF MALFUNCTION. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF BEAD BLOCK. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841438 | BEAD BLOCK | SINGLE USE IMPLANTABLE MEDICAL DEVICE | HCG | BIOCOMPATIBLES UK LTD | 700-900 MICROMETERS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R | MORPHINE |