MAUDE Adverse Event Report: BIOCOMPATIBLES U.K. LIMITED DC BEAD; EMBOLIC AGENT

Model Number 100-300UM

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Cardiopulmonary Arrest (1765); Death (1802); Loss of consciousness (2418); Polydipsia (2604)

Event Date 01/14/2015

Event Type  Death  

Event Description

This report combines initial and follow up information concerning a (b)(6) female patient.The information was received from a user facility via a partner organization on (b)(6) 2015 and (b)(6) 2015 respectively.The patient's concomitant diseases include parkinson's disease and (b)(6).On (b)(6) 2015, the patient was hospitalized.The size of the tumor was 35mm, s8; child-pugh: a and performance status: o.On (b)(6) 2015 between 11:10 and 12:03, tace was performed using dc bead (100-300 um).Four to five vials were loaded with 75 ml/100mg of epirubicin (epirubicin hydrochloride) the supernatant was discarded and the drug was injected through a-8 branch (tumor diameter: 3.8 cm) for hcc in segment viii of the liver.A complete disappearance of tumor staining was confirmed.At 16:00, bp 86/71, pulse (p) 111 and at 16:20, bp 126/84.At around 18:00, the patient complained of persistent upper right abdominal pain, and an abdominal echography was performed.No hemorrhage was confirmed.Blood pressure (bp) 121/78 and pulse rate (pr) 97, body temperature (bt) 36.3 degrees c and respiratory rate 22 breaths per minute, the patient had a clear consciousness.At 19:20, pentagin (pentazocine) 1a was administered, bp 118/80 and pr 95.At 22:10, bp 112/76, p 103, bt 36.5 degrees c, respiratory rate 23 breaths per minute.On (b)(6) 2015, at 0:00, bp 118/61, p108.At 0:10, the pain was resolving.The patient complained of being thirsty and drank water with the assistance of a nurse, bp 118/61 and pr 108.At 2:20, the monitor alarm showed that the patient's consciousness was lost and her pulse rate was in the 40's and her blood pressure was not measureable.At 2:23, cardiopulmonary arrest was confirmed and cardiopulmonary resuscitation was initiated and at 2:29, an emergency physician performed intubation and started artificial ventilation.At 2:40, adrenaline was given as a bolus injection.Heart rate (hr) 70.At around 3:00 and 3:30, the patient's death was confirmed.Autopsy results and cause of death was revealed as intra-abdominal bleeding due to hcc (hepatocellular carcinoma) rupture.Physician commented that hcc rupture was following deb-tace procedure.The reporting physician stated that hcc rupture and death were probably related to deb tace.

Manufacturer Narrative

Dc bead with epirubicin was reported to have been used in the treatment of this patient.Dc bead is not registered to be used in combination with epirubicin.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.Company medical assessment: patient underwent deb-tace procedure, soon thereafter she developed abdominal pain, the same day she later developed hypotension and later died.Autopsy showed tumor rupture.Rupture of hepatocellular carcinoma (hcc) following transarterial chemoembolization is a rare but life-threatening complication.Large tumor size, superficial or exophytic tumors as well as portal vein thrombosis and comorbidities such as primary hypertension, diabetes or peripheral artery disease may be predisposing factors for rupture.This event is medically reportable.This event is currently under investigation by the manufacturer and the conclusions of this investigation/any new information received will be communicated as a follow-up report.

Manufacturer Narrative

A review of the batch records (manufacturing batch records, filling and primary packaging batch records and test results) for lot v10529 was performed.There were no indications of any issues with this batch of beads or primary packaging components and all batch release testing for lot number v10529 were within specification.Medical assessment: new information confirms that the patient received 80% of a single vial and not 4 to 5 dc bead vials.However, as a "vascular lake" was noted during the procedure, which could represent blood extravasation from the artery injected.If extravasation did indeed occur, it could explain the patient's subsequent course.Volume injected would be a contributing factor, so it is reassuring that there was no apparent excess of dc bead injected.However, volume is not the only relevant potential factor, as pressure and rapidity of injection are also important issues in this regard.Therefore, it remains possible that user error may have contributed to this event.Additional information was received from the physician via the company distributor on april 24, 2015: it was reported that as part of the dc bead (100-300 pm) tace procedure the patient only received 0.8 ml (80%) of a single vial and not four to five vials of dc bead as previously reported.The patient received the procedure in the a-8 branch (tumor diameter: 3.8 cm) and complete disappearance of tumor staining was confirmed.It was reported that the treating physician has a good experience performing tace procedures.

Manufacturer Narrative

The initial medical assessment stated that the pt's rupture of hcc following tac is a rare but life-threatening complication.Large size tumor, superficial or exophytic tumors as well as pvt and co-morbidities such as primary hypertension, diabetes or peripheral artery disease may be a predisposing factors for the rupture.The f/u medical assessment indicated that a "vascular lake" was present during the deb-tace procedure and was no longer present at the close of the procedure; this could simply indicate embolization of the blood supply to it or could indicate over filling during the procedure.The involvement of user error is increased, this case is medically reportable.This event is currently, under investigation by the manufacturer and the conclusions of this investigation/any new information received will be communicated as a follow-up report.

Event Description

Previously reported information concerns a (b)(6) female pt.Past medical history unk.Concomitant drugs include epirubicin hydrochloride, iopamidol, lidocaine, pentazocine, ramosetron hydrochloride, cefazolin sodium and alprostadil.Pt's concomitant diseases include parkinson's disease and auto-immune hepatitis.The pt was hospitalized.The size of the tumor was 35 mm, s8; childpugh: a and performance status: 0.Tace was performed using dc bead (100-300 um; lot number: 3zq02f).Four to five vials were loaded with 75 ml/100 mg of epirubicin (epirubicin hydrochloride) the supernatant was discarded and the drug was injected through a-8 branch (tumor diameter: 3.8 cm) for hcc in segment viii of the liver.A complete disappearance of tumor staining was confirmed.On the same day of the procedure, bp 86/71, pulse (p) 111 and the pt complained of persistent upper right abdominal pain, and an abdominal echography was performed.On hemorrhage was confirmed and all the vital signs were normal.Later the same day, pentagon (pentazocine) 1a was administered, bp 118/80 and pr 95.The next day the pain was resolving.The patient complained of being thirsty and drank water with the assistance of a nurse, bp 118/61 pr and 108, later the patient's consciousness was lost and her pulse rate was in the 40s and her blood pressure was not measurable.The next day cardiopulmonary arrest was confirmed and cardiopulmonary resuscitation was initiated and at 2:29, an emergency physician performed intubation and started artificial ventilation.At 2:40, adrenaline was given as a bolus injection.Heart rate (hr) 70.At around 3:00 and 3:30, the patient's death was confirmed.Autopsy results and cause of death was w) revealed as intra-abdominal bleeding due to hcc (hepatocellular carcinoma) rupture.Physician commented e that hcc rupture was following deb-tace procedure.The reporting physician stated that hcc rupture and death were probably related to deb tace.Additional information was received from a user facility via the company distributor on march 13, 2015.The patient's concomitant diseases include hypertension and child-pugh classification; class a, 5 points.It was reported that the patient had no hepatic cirrhosis or thrombosis in the past or at the time of the procedure.The patient's tumor size (maximum diameter): 35 mm, location immediately below the hepatic capsule, raised from surface of the liver and no extrahepatic infiltration.No vascular lake before tace on (b)(6) 2015 was observed.

Manufacturer Narrative

The manufacturer's investigation into this complaint was complete; the potential contributory factors were investigated and assessed as part of this complaint.No singular root cause was identified on this occasion however a number of potential root causes could not be ruled out which include the patient's tumor characteristics, pre-disposing factors and a potential user error due to over embolization.

Event Description

Hypertension and child-pugh classification; class a, 5 points.It was reported that the patient had no hepatic cirrhosis or thrombosis in the past or at the time of the procedure.The patient's tumor size (maximum diameter): 35 mm, s8 location immediately below the hepatic capsule, raised from surface of the liver and no extrahepatic infiltration.No vascular lake before tace on (b)(6) 2015 was observed.The patient was hospitalized.The clinical test results before tace showed alt: 35; ast: 28; tbi11: 1.1; alp: na; crp: na and hb: 14.4.Vascular lake was observed during tace on (b)(6) 2015.No treatment for vascular lake (disappeared on digital subtraction angiography (dsa) during tace) was given.Tace was performed using dc bead (100-300pm; lot number: 3zq02f).A 0.8 ml (80%) of a single vial with 75 ml/100mg of epirubicin (epirubicin hydrochloride) the supernatant was discarded and the drug was injected through a-8 branch (tumor diameter: 3.8 cm) for hcc in segment viii of the liver.On (b)(6) 2015, at 11:10-12:03, tace was complete.A complete disappearance of tumor staining was confirmed.On the same day of the procedure, bp 86/71, pulse (p) 111 and the patient complained of persistent upper right abdominal pain, and an abdominal to echography was performed.No hemorrhage was confirmed and all the vital signs were normal.Later the same day, pentagon (pentazocine) 1a was administered, bp 118/80 and pr 95.On (b)(6) 2015 at 13:30, the patient experienced the initial symptoms of hcc rupture which include right upper quadrant pain.The next day the pain was resolving.The patient complained of being thirsty and drank water with the assistance of a nurse, bp 118/61 and pr 108, later the patient's consciousness was lost and her pulse rate was in the 40s and her blood pressure was not measurable.The next day cardiopulmonary arrest was confirmed and cardiopulmonary resuscitation was initiated and at 2:29, an emergency physician performed intubation and started artificial ventilation.At 2:40, adrenaline was given as a bolus injection.Heart rate (hr) 70.At around 3:00 and 3:30, the patient's death was confirmed.On (b)(6) 2015 the patient died during emergency resuscitation.The reporter stated that dc bead was observed in the tumor.

• Brand Name: DC BEAD
• Type of Device: EMBOLIC AGENT
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; chapman house, farnham bus.; park, weydon ln; farnham, surrey england GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: 252732732
• MDR Report Key: 4637619
• MDR Text Key: 5577952
• Report Number: 3002124545-2015-00004
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor,distributor,forei
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300UM
• Device Lot Number: V10529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALPROSTADIL; CEFAZOLIN SODIUM; RAMOSETRON HYDROCHLORIDE; PENTAZOCINE; LIDOCAINE
• Patient Outcome(s): Death
• Patient Age: 73 YR