MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; SINGLE USE IMPLANTABLE MEDICAL DEVICE

Lot Number 1699088

Device Problems Therapy Delivered to Incorrect Body Area (1508); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2016

Event Type  No Answer Provided  

Event Description

Spheres all went to the right lobe when they were intended for the left lobe [device deployment issue].Catheter placement not confirmed [device use error].Case description: initial information received on (b)(6) 2016: this spontaneous adverse event report was received from physician via a company representative and a second company representative regarding a patient, gender and age unknown.The patient's medical history included cancer (unspecified) in both lobes of the liver and previous therasphere treatment to "right lobe a month or two ago in 2016".The patient's concomitant medications were unknown.The patient received therasphere , unknown dose, intended for the left lobe of liver, administered to the right lobe of liver (lot number and expiration date unknown) on an unspecified date in 2016.On an unspecified date in 2016, the spheres all went to the right lobe when they were intended for the left lobe.The patient was given a dose of therasphere intended for the left lobe.The total y-90 injected was much smaller than the activity injected previously in the right lobe, however it was not intended to treat the right lobe twice.During the procedure catheter placement was not confirmed.A pet scan was done post- treatment as part of a research program.There was no adverse event reported and no indication of patient harm.The treatment and outcome of the event is unknown.The physician indicated that the cause of the spheres all went to the right lobe when they were intended for the left lobe were due to the fact that he did not know whether he could disconnect, deliver contrast and confirm placement of the catheter.Therefore, catheter placement was not confirmed.The company has assessed the event spheres all went to the right lobe when they were intended for the left lobe as serious (medically significant) due to the potential for patient harm.The event of catheter placement not confirmed is considered to be non-serious.Additional information will be requested.Case assessment the reported events of device deployment issue and device use error and are considered unlisted according to the therasphere current reference safety information.The company considers the events of device deployment issue and device use error to be not assessable.This single case report does not modify the risk benefit balance of therasphere.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

Spheres all went to the right lobe when they were intended for the left lobe/catheter used to deliver the microspheres moved [device deployment issue] catheter placement not confirmed [device use error] case description: initial information received on 24-may-2016: this spontaneous adverse event report was received from physician via a company representative and a second company representative regarding a patient, gender and age unknown.The patient's medical history included cancer (unspecified) in both lobes of the liver and previous therasphere treatment to "right lobe a month or two ago in 2016".The patient's concomitant medications were unknown.The patient received therasphere , unknown dose, intended for the left lobe of liver, administered to the right lobe of liver (lot number and expiration date unknown) on an unspecified date in 2016.On an unspecified date in 2016, the spheres all went to the right lobe when they were intended for the left lobe.The patient was given a dose of therasphere intended for the left lobe.The total y-90 injected was much smaller than the activity injected previously in the right lobe, however it was not intended to treat the right lobe twice.During the procedure catheter placement was not confirmed.A pet scan was done post- treatment as part of a research program.There was no adverse event reported and no indication of patient harm.The treatment and outcome of the event is unknown.The physician indicated that the cause of the spheres all went to the right lobe when they were intended for the left lobe were due to the fact that he did not know whether he could disconnect, deliver contrast and confirm placement of the catheter.Therefore, catheter placement was not confirmed.The company has assessed the event spheres all went to the right lobe when they were intended for the left lobe as serious (medically significant) due to the potential for patient harm.The event of catheter placement not confirmed is considered to be non-serious.Additional information will be requested.Follow-up information was received on 25-may-2016 via a company representative and from the nuclear regulatory commission (nrc) medical events via another company representative, (b)(6) 2016 from a product complaint investigation report, and (b)(6) 2016 from the initial reporting physician: the patient is male and was (b)(6) at the time of the event.Demographics were updated.The patient's medical history included poorly differentiated bilobar biphenotypic hepatocellular carcinoma (in multiple locations of the liver), diabetes, hypertension, nausea, and chemotherapy treatment.The patient's concomitant medications included glipizide, metformin, and januvia (all for indication of diabetes); atenolol for hypertension; zofran for nausea; and cisplatin and gemcitabine as chemotherapy.The therasphere administration date was (b)(6) 2016 and was given for the indication of biphenotypic hepatocellular carcinoma (lot number 1699088, vial #81).The presented dose was 4.15 gbq (actual dose 4.07 gbq).Additional information received documented the prescribed dose was 120 gy (3.3 gbq) and the delivered dose was approximately 118.5 gy as determined by bremmstrahlung imaging (conflicting with previously reported information).On the administration date of therasphere (b)(6) 2016), the catheter used to deliver the microspheres to the target tissue had moved.The catheter moved between the time when it was put into position and the time when the connection was made with the therasphere administration set.As a result, the dose was delivered to the previously treated "volume" (but was intended for the right lobe of the liver segments 5,6,7 and 8) (estimated volume of 1290 ml) but was actually given to the medial segment 4 (left lobe) (estimated volume 330 ml) that was previously treated and there was some residual cancer at this location.This dose was not expected to have detrimental effects on the patient.It was anticipated that right lobe segments 5,6,7,8 will be treated at a future time.(this information regarding site of delivery of the microspheres conflicts with the information provided by the administering physician).As of (b)(6) 2016, the initial reporting physician stated there were no adverse clinical events or toxicity attributed to the second right lobe dose administered on (b)(6) 2016.A therasphere product complaint investigation report of (b)(6) 2016 "root cause analysis conclusion" documented: the root cause of the event is attributed to use error: failure to confirm the catheter position as directed by the ifu/checklist.This resulted in the microspheres going to the wrong part of the liver.The "risk assessment" documented: there is low risk associated with this event wherein the patient received the dose to the wrong portion of the liver, since that portion of the liver had previously been treated with therasphere and had some residual tumors that may in fact benefit from re-treatment.Risk of non-target radiation is a known risk for the product.No further follow-up is expected.This report is final.Case assessment: the reported events of device deployment issue and device use error and are considered unlisted according to the therasphere current reference safety information.The company considers the events of device deployment issue and device use error to be not assessable.The root cause of the event is attributed to use error: failure to confirm the catheter position as directed by the ifu/checklist.This resulted in the microspheres going to the wrong part of the liver.There is low risk associated with this event wherein the patient received the dose to the wrong portion of the liver, since that portion of the liver had previously been treated with therasphere and had some residual tumors that may in fact benefit from re-treatment.Risk of non-target radiation is a known risk for the product.This single case report does not modify the risk benefit balance of therasphere.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: THERASPHERE
• Type of Device: 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: 11 hines road, suite 200; ottawa, ontario K2K 2-X1
• MDR Report Key: 5697424
• MDR Text Key: 46596059
• Report Number: 3002124545-2016-00043
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1699088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• 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: 50 YR