MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD DC BEAD; HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE

Model Number 100-300 MICROM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/04/2016

Event Type  No Answer Provided  

Event Description

Intratumor hemorrhage [hepatic haemorrhage]; loaded with farmorubicin [off label use of device].Case description: intiial information was received on 18-apr-2016: this spontaneous medical device report was received from a physician regarding a (b)(6) female patient.The patient's medical history included chronic thyroiditis, hepatic cirrhosis, right ureteral tumor (at age (b)(6)), skin cancer in the occipital scalp (at age (b)(6)), and hepatocellular carcinoma (2 tumors, 30 mm and the approximately 40 mm) also reported as hepatic cancer (3 cm, hepatic surface).The patient's concomitant medications were unknown.The patient received dc bead 0.6 vial, 100- 300 micrometer (lot number, expiration date unknown) as transarterial chemoembolization (tace) for hepatic cancer to the s7-8 and s2 subsegments, loaded with farmorubicin (epirubicin hydrochloride) 50 mg/vial) on (b)(6) 2016.After tace (the degree of radioembolization was reported to be "slow" (rate of disappearance of the contrast medium, 5 heartbeats as a reference), a vascular lake appeared, and gelpart (porous gelatin particles) was infused to perform additional embolization to vascular lake.On (b)(6) 2016, the patient developed a intratumor hemorrhage.On (b)(6) 2016, the patient complained of abdominal pain.An intratumor hemorrhage was confirmed, and a trial puncture was conducted by needlestick.The aspirate was a thick bloody fluid.Subsequently, hemostasis was confirmed by urgent angiogram.Vital signs were stable and the patient had a clear sensorium.Treatment included gelatin sponge (1-mm particles) infused into the lateral segment (particularly a2), and embolization was finished when the blood flow into the lateral segment was completely stopped.It was reported that the patient received two radiofrequency ablation treatments (dates unspecified).On an unspecified date in (b)(6) 2016, the patient recovered from the intratumor hemorrhage.The physician did not assess the severity of the intratumor hemorrhage but assessed the intratumor hemorrhage as possibly related to the administration of dc bead.The company considers the event of intratumor hemorrhage to be serious (medically significant) and to be an unanticipated serious deterioration in health; and off-label use as non-serious.Case assessment: the reported event of hepatic hemorrhage is considered to be listed according to the dc bead current reference safety information and off-label use of device is considered to be unlisted.In agreement with the reporting physician, the company considers the hepatic hemorrhage to be possibly related to the administration of dc bead and also possibly related to gelpart (co-suspect device).The relatedness of off-label use of device is not assessable.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

Event Description

Intratumor hemorrhage [hepatic haemorrhage], loaded with farmorubicin [off label use of device].Case description: initial information was received on 18-apr-2016: this spontaneous medical device report was received from a physician regarding a (b)(6) female patient.The patient's medical history included chronic thyroiditis, hepatic cirrhosis, right ureteral tumor (at (b)(6)), skin cancer in the occipital scalp (at (b)(6)), and hepatocellular carcinoma (2 tumors, 30 mm and the approximately 40 mm) also reported as hepatic cancer (3 cm, hepatic surface).The patient's concomitant medications were unknown.The patient received dc bead 0.6 vial, 100- 300 micrometer (lot number, expiration date unknown) as transarterial chemoembolization (tace) for hepatic cancer to the s7-8 and s2 subsegments, loaded with farmorubicin (epirubicin hydrochloride) 50 mg/vial) on (b)(6) 2016.After tace (the degree of radioembolization was reported to be "slow" (rate of disappearance of the contrast medium, 5 heartbeats as a reference), a vascular lake appeared, and gelpart (porous gelatin particles) was infused to perform additional embolization to vascular lake.On (b)(6) 2016, the patient developed a intratumor hemorrhage.On (b)(6) 2016, the patient complained of abdominal pain.An intratumor hemorrhage was confirmed, and a trial puncture was conducted by needlestick.The aspirate was a thick bloody fluid.Subsequently, hemostasis was confirmed by urgent angiogram.Vital signs were stable and the patient had a clear sensorium.Treatment included gelatin sponge (1-mm particles) infused into the lateral segment (particularly a2), and embolization was finished when the blood flow into the lateral segment was completely stopped.It was reported that the patient received two radiofrequency ablation treatments (dates unspecified).On an unspecified date in (b)(6) 2016, the patient recovered from the intratumor hemorrhage.The physician did not assess the severity of the intratumor hemorrhage but assessed the intratumor hemorrhage as possibly related to the administration of dc bead.The company considers the event of intratumor hemorrhage to be serious (medically significant) and to be an unanticipated serious deterioration in health; and off-label use as non-serious.Follow-up information was received on 05-may-16.The dc bead lot number and expiration date are both unknown.The only concomitant medication was noted to be epirubicin.There is no other information expected.This report is final.Case assessment: the reported event of hepatic hemorrhage is considered to be listed according to the dc bead current reference safety information and off-label use of device is considered to be unlisted.In agreement with the reporting physician, the company considers the hepatic hemorrhage to be possibly related to the administration of dc bead and also possibly related to gelpart (co-suspect device).The relatedness of off-label use of device is not assessable.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

• Brand Name: DC BEAD
• Type of Device: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon lane; farnham, surrey GU9 8-QL ; 4125273273
• MDR Report Key: 5614723
• MDR Text Key: 44011948
• Report Number: 3002124545-2016-00028
• 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,o
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 100-300 MICROM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR