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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Abdominal Pain (1685); Fever (1858); Gangrene (1873); Unspecified Infection (1930); Ischemia (1942); Necrosis (1971); Respiratory Distress (2045); Swelling (2091); Tachycardia (2095); Vomiting (2144)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Dc bead with doxorubicin hydrochloride was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Acute acalculous gangrenous cholecystitis [cholecystitis acute].Tace microspheres identified in the gallbladder wall vessels [device deployment issue].Case description: initial information received on 07-jul-2016: this literature case report was published in 2015 in the journal of gastrointestinal surgery by karavias et al.With the title "gangrenous cholecystitis related to transcatheter arterial chemoembolization (tace) treatment for hepatocellular carcinoma" and concerned a (b)(6)-year old male patient.The patient's medical history included (b)(6), newly diagnosed liver tumor in (b)(6) 2013 and normal serum alpha-fetoprotein (afp) levels.A multiphase-multidetector ct showed a typical hypervascularized hepatocellular carcinoma (hcc) lesion in segment vi, for which the patient underwent segmental liver resection.At his 12-months follow-up, contrast-enhanced ct showed a large hcc lesion in segment vii, measuring 7.8 by 6.2 cm, with irregular margins and the presence of a tumor thrombus in the portal vein.The imaging findings were evaluated by the multidisciplinary liver team, and the patient was admitted for transcatheter arterial chemoembolization (tace) with drug-eluting beads (deb).No concomitant medications were reported.On an unspecified date in 2014 the patient underwent tace with dc bead (lot number and expiration date not reported) loaded with doxorubicin, super-selectively injected into the feeding vessels of the tumor through the right hepatic artery.His postinterventional recovery was uneventful, and the patient was discharged from the hospital 48 hours after tace.On an unspecified date in 2014, 48 hours after his discharge, the patient presented with high fever, tachycardia, tachypnea, abdominal pain, and vomiting.On examination, he had right subcostal pain with guarding.The patient had marginal leukocytosis of 13 x10^9/l with 86 % polymorphs and elevated c-reactive protein.Liver function, blood, and urine amylase were normal.Abdominal ultrasound showed pericholecystic fluid and gas in the gall bladder wall.And contrast-enhanced ct showed an over-distended gallbladder, with thick, irregular wall, intraluminal membranes and stranding in the fat surrounding the fundus.The patient underwent cholecystectomy and was discharged from the hospital 48 hours later.Pathology examination confirmed the diagnosis of acute acalculous gangrenous cholecystitis with extensive ischemic changes and focal transmural necrosis and identified the tace microspheres in the gallbladder wall vessels [device misdeployment (location)].At last follow-up in (b)(6) 2015, the patient remained well and was treated with sorafenib.The author assessed the event acute acalculous gangrenous cholecystitis as severe and related to the use of dc bead.The company assesses the events acute acalculous gangrenous cholecystitis and tace microspheres in the gallbladder wall vessels [device misdeployment (location)] as serious (hospitalized, medically significant).Case comment: cholecystitis acute and device deployment issue are considered listed according to the dc bead current reference safety information.The author assessed the event acute acalculous gangrenous cholecystitis as related to the dc bead.In agreement with the author the company considers that acute acalculous gangrenous cholecystitis is related to the use of dc bead.Tace microspheres in the gallbladder wall vessels [device misdeployment (location)] is non-assessable as an event.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.

Manufacturer Narrative

Dc bead with doxorubicin hydrochloride was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Acute acalculous gangrenous cholecystitis [cholecystitis acute], tace microspheres identified in the gallbladder wall vessels [device deployment issue].Case description: initial information received on 07-jul-2016: this literature case report was published in 2015 in the journal of gastrointestinal surgery by karavias et al.With the title "gangrenous cholecystitis related to transcatheter arterial chemoembolization (tace) treatment for hepatocellular carcinoma" and concerned a (b)(6) male patient.The patient's medical history included (b)(6), newly diagnosed liver tumor in (b)(6) 2013 and normal serum alpha-fetoprotein (afp) levels.A multiphase-multidetector ct showed a typical hypervascularized hepatocellular carcinoma (hcc) lesion in segment vi, for which the patient underwent segmental liver resection.At his 12-months follow-up, contrast-enhanced ct showed a large hcc lesion in segment vii, measuring 7.8 by 6.2 cm, with irregular margins and the presence of a tumor thrombus in the portal vein.The imaging findings were evaluated by the multidisciplinary liver team, and the patient was admitted for transcatheter arterial chemoembolization (tace) with drug-eluting beads (deb).No concomitant medications were reported.On an unspecified date in 2014 the patient underwent tace with dc bead (lot number and expiration date not reported) loaded with doxorubicin, super-selectively injected into the feeding vessels of the tumor through the right hepatic artery.His postinterventional recovery was uneventful, and the patient was discharged from the hospital 48 hours after tace.On an unspecified date in 2014, 48 hours after his discharge, the patient presented with high fever, tachycardia, tachypnea, abdominal pain, and vomiting.On examination, he had right subcostal pain with guarding.The patient had marginal leukocytosis of 13 x10^9/l with 86 % polymorphs and elevated c-reactive protein.Liver function, blood, and urine amylase were normal.Abdominal ultrasound showed pericholecystic fluid and gas in the gall bladder wall.And contrast-enhanced ct showed an over-distended gallbladder, with thick, irregular wall, intraluminal membranes and stranding in the fat surrounding the fundus.The patient underwent cholecystectomy and was discharged from the hospital 48 hours later.Pathology examination confirmed the diagnosis of acute acalculous gangrenous cholecystitis with extensive ischemic changes and focal transmural necrosis and identified the tace microspheres in the gallbladder wall vessels [device misdeployment (location)].At last follow-up in (b)(6) 2015, the patient remained well and was treated with sorafenib.The author assessed the event acute acalculous gangrenous cholecystitis as severe and related to the use of dc bead.The company assesses the events acute acalculous gangrenous cholecystitis and tace microspheres in the gallbladder wall vessels [device misdeployment (location)] as serious (hospitalized, medically significant).Additional information on 05-aug-2016: follow up information has been sought.As of 05-aug-2016 no additional information has been received.Case comment: cholecystitis acute and device deployment issue are considered listed according to the dc bead current reference safety information.The author assessed the event acute acalculous gangrenous cholecystitis as related to the dc bead.In agreement with the author the company considers that acute acalculous gangrenous cholecystitis is related to the use of dc bead.Tace microspheres in the gallbladder wall vessels [device misdeployment (location)] is non-assessable as an event.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.

Manufacturer Narrative

Dc bead with doxorubicin hydrochloride was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Acute acalculous gangrenous cholecystitis [cholecystitis acute], tace microspheres identified in the gallbladder wall vessels [device deployment issue].Case description: initial information received on 07-jul-2016: this literature case report was published in 2015 in the journal of gastrointestinal surgery by karavias et al.With the title "gangrenous cholecystitis related to transcatheter arterial chemoembolization (tace) treatment for hepatocellular carcinoma" and concerned a (b)(6) male patient.The patient's medical history included (b)(6)-induced cirrhosis, newly diagnosed liver tumor in july 2013 and normal serum alpha-fetoprotein (afp) levels.A multiphase-multidetector ct showed a typical hypervascularized hepatocellular carcinoma (hcc) lesion in segment vi, for which the patient underwent segmental liver resection.At his 12-months follow-up, contrast-enhanced ct showed a large hcc lesion in segment vii, measuring 7.8 by 6.2 cm, with irregular margins and the presence of a tumor thrombus in the portal vein.The imaging findings were evaluated by the multidisciplinary liver team, and the patient was admitted for transcatheter arterial chemoembolization (tace) with drug-eluting beads (deb).No concomitant medications were reported.On an unspecified date in 2014 the patient underwent tace with dc bead (lot number and expiration date not reported) loaded with doxorubicin, super-selectively injected into the feeding vessels of the tumor through the right hepatic artery.His postinterventional recovery was uneventful, and the patient was discharged from the hospital 48 hours after tace.On an unspecified date in 2014, 48 hours after his discharge, the patient presented with high fever, tachycardia, tachypnea, abdominal pain, and vomiting.On examination, he had right subcostal pain with guarding.The patient had marginal leukocytosis of 13 x10^9/l with 86 % polymorphs and elevated c-reactive protein.Liver function, blood, and urine amylase were normal.Abdominal ultrasound showed pericholecystic fluid and gas in the gall bladder wall.And contrast-enhanced ct showed an over-distended gallbladder, with thick, irregular wall, intraluminal membranes and stranding in the fat surrounding the fundus.The patient underwent cholecystectomy and was discharged from the hospital 48 hours later.Pathology examination confirmed the diagnosis of acute acalculous gangrenous cholecystitis with extensive ischemic changes and focal transmural necrosis and identified the tace microspheres in the gallbladder wall vessels [device misdeployment (location)].At last follow-up in june 2015, the patient remained well and was treated with sorafenib.The author assessed the event acute acalculous gangrenous cholecystitis as severe and related to the use of dc bead.The company assesses the events acute acalculous gangrenous cholecystitis and tace microspheres in the gallbladder wall vessels [device misdeployment (location)] as serious (hospitalized, medically significant).Additional information on 05-aug-2016: follow up information has been sought.As of 05-aug-2016 no additional information has been received.Final assessment on 02-sep-2016: follow-up information has been sought to further investigate the events but no new information has been received.After three follow-up attempts the case is considered lost to follow up.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.This is a final report.Case comment: cholecystitis acute and device deployment issue are considered listed according to the dc bead current reference safety information.The author assessed the event acute acalculous gangrenous cholecystitis as related to the dc bead.In agreement with the author the company considers that acute acalculous gangrenous cholecystitis is related to the use of dc bead.Tace microspheres in the gallbladder wall vessels [device misdeployment (location)] is non-assessable as an event.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 ; 1252 732 7
• MDR Report Key: 5804569
• MDR Text Key: 49951238
• Report Number: 3002124545-2016-00053
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• 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): Hospitalization; Other
• Patient Age: 69 YR