MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOZENE MICROSPHERES; EMBOLIC DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Paralysis (1997)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter healthcare facility: (b)(6).Lin, gang-hua, and yu-lueng shih."paraplegia following transarterial chemoembolisation for hepatocellular carcinoma: a case report." acta chirurgica belgica 121.6 (2021): 437-440.

Event Description

It was reported via literature article that paralysis occurred.Background: transarterial chemoembolisation (tace) is considered standard treatment for intermediate-stage hepatocellular carcinoma (hcc).Although tace is viewed as a safe and effective procedure, it may still present with various complications, including spinal cord injury, though very rarely.Methods: a 74-year-old male was diagnosed with non-b, non-c hcc, segment 4, ct2n0m0, ajcc stage ii, bclc stage b.Angiography had shown a hypervascular tumour stain indicating that both t10 and t11 were tumour-feeding arteries, tace then performed.After tace, loss of sensation and motor functions involving the trunk below the umbilicus and both lower extremities were noted.The patient immediately underwent steroid pulse therapy.However, 100 days after tace, the symptoms showed no improvement.Discussion: because of anatomy and neurological distribution, it is conceivable that the embolic materials originating from the tace procedure might have led to an embolic event with a serious manifestation, although the blood supply of the spinal cord encompasses multiple anastomoses.Conclusion: spinal cord injury is an extremely rare but grave complication of tace.Paraplegia may result from inadvertent embolisation of spinal branches arising from intercostal or lumbar collateral vessels.This case highlights the necessity of evaluating and choosing the vessels before starting tace to achieve a good outcome.

Manufacturer Narrative

Correction: h6 - patient code: high blood pressure / hypertension removed.E1 - initial reporter healthcare facility: (b)(6).(b)(6)."paraplegia following transarterial chemoembolisation for hepatocellular carcinoma: a case report." acta chirurgica belgica 121.6 (2021): 437-440.

Event Description

It was reported via literature article that paralysis occurred.Background: transarterial chemoembolisation (tace) is considered standard treatment for intermediate-stage hepatocellular carcinoma (hcc).Although tace is viewed as a safe and effective procedure, it may still present with various complications, including spinal cord injury, though very rarely.Methods: a 74-year-old male was diagnosed with non-b, non-c hcc, segment 4, (b)(6), ajcc stage ii, bclc stage b.Angiography had shown a hypervascular tumour stain indicating that both t10 and t11 were tumour-feeding arteries, tace then performed.After tace, loss of sensation and motor functions involving the trunk below the umbilicus and both lower extremities were noted.The patient immediately underwent steroid pulse therapy.However, 100 days after tace, the symptoms showed no improvement.Discussion: because of anatomy and neurological distribution, it is conceivable that the embolic materials originating from the tace procedure might have led to an embolic event with a serious manifestation, although the blood supply of the spinal cord encompasses multiple anastomoses.Conclusion: spinal cord injury is an extremely rare but grave complication of tace.Paraplegia may result from inadvertent embolisation of spinal branches arising from intercostal or lumbar collateral vessels.This case highlights the necessity of evaluating and choosing the vessels before starting tace to achieve a good outcome.

• Brand Name: EMBOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15095054
• MDR Text Key: 296499850
• Report Number: 2134265-2022-07861
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male