MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

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

Patient Problems Cerebrospinal Fluid Leakage (1772); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Age at time of event estimated using average age at presentation.Date of event estimated using beginning of first month of study period.The study period was between january 2012 to december 2017.Abouzeid et al.(2021).Multidisciplinary management of juvenile nasopharyngeal angiofibroma.The egyptian journal of neurology, psychiatry and neurosurgery, 57(167).Doi.Org/10.1186/s41983-021-00414-0.

Event Description

It was reported via literature article that following a contour embolization procedure, one patient had a csf leak that was treated medically, and one patient had tumor recurrence after 1.5 years and was treated by trans-arterial embolization followed by surgical resection.Juvenile nasopharyngeal angiofibroma (jna) is a rare benign, but the locally aggressive, vascular tumor that occurs almost exclusively in young men.Although this tumor accounts for only about 0.5% of head and neck tumors, it is by far the most common benign nasopharyngeal neoplasm.It is presented typically with epistaxis, obstructive symptoms, and chronic otomastoiditis.The examination of this tumor reveals pale reddish-blue mass.The tumor is seen on imaging as vividly augmenting soft-tissue mass centered on the sphenopalatine foramen.The treatment of choice is usually surgical resection; either open or endoscopic.Pre-operative embolization is usually done to help with hemostasis.This study aims to address the efficiency and the safety of endovascular modality in jna.The study period was between january 2012 to december 2017, involving 20 male patients with ages ranging from 6 to 20 years.The average age at presentation was 13 years.Preoperative trans-arterial embolization was done, followed by endoscopic surgical resection by ent surgeons.All patients were subjected to clinical and radiological imaging evaluation pre embolization, post embolization, and post endoscopic resection.All patients had clinical and radiological follow-ups for at least 1 year.All patients underwent successful embolization with total obliteration of vascular blush of the tumor in 15 patients, and near-total obliteration of blush in 5 patients.These 5 patients had supplementary feeders from the internal carotid artery or external carotid artery with dangerous anastomosis to the internal carotid artery.The embolization of these small feeders is technically difficult and carries risk for dangerous complications.Ent surgeons reported no significant bleeding in these cases with near-total embolization.No permanent morbidity or mortality, related to surgical techniques in this series, was shown other than one patient revealed csf leak the treated medically.Only one patient had recurrence after 1.5 years and was treated by trans-arterial embolization followed by surgical resection.

Event Description

It was reported via literature article that following a contour embolization procedure, one patient had a csf leak that was treated medically, and one patient had tumor recurrence after 1.5 years and was treated by trans-arterial embolization followed by surgical resection.Juvenile nasopharyngeal angiofibroma (jna) is a rare benign, but the locally aggressive, vascular tumor that occurs almost exclusively in young men.Although this tumor accounts for only about 0.5% of head and neck tumors, it is by far the most common benign nasopharyngeal neoplasm.It is presented typically with epistaxis, obstructive symptoms, and chronic otomastoiditis.The examination of this tumor reveals pale reddish-blue mass.The tumor is seen on imaging as vividly augmenting soft-tissue mass centered on the sphenopalatine foramen.The treatment of choice is usually surgical resection; either open or endoscopic.Pre-operative embolization is usually done to help with hemostasis.This study aims to address the efficiency and the safety of endovascular modality in jna.The study period was between january 2012 to december 2017, involving 20 male patients with ages ranging from 6 to 20 years.The average age at presentation was 13 years.Preoperative trans-arterial embolization was done, followed by endoscopic surgical resection by ent surgeons.All patients were subjected to clinical and radiological imaging evaluation pre embolization, post embolization, and post endoscopic resection.All patients had clinical and radiological follow-ups for at least 1 year.All patients underwent successful embolization with total obliteration of vascular blush of the tumor in 15 patients, and near-total obliteration of blush in 5 patients.These 5 patients had supplementary feeders from the internal carotid artery or external carotid artery with dangerous anastomosis to the internal carotid artery.The embolization of these small feeders is technically difficult and carries risk for dangerous complications.Ent surgeons reported no significant bleeding in these cases with near-total embolization.No permanent morbidity or mortality, related to surgical techniques in this series, was shown other than one patient revealed csf leak the treated medically.Only one patient had recurrence after 1.5 years and was treated by trans-arterial embolization followed by surgical resection.It was further corrected that the csf leak complication is related to the procedure that occurred after the contour procedure, and is not related to contour procedure or the contour device.

Manufacturer Narrative

Corrections: h6 patient codes and impact codes were updated and b5 revised as the adverse event is not related to the contour device.A2: age at time of event estimated using average age at presentation.B3: date of event estimated using beginning of first month of study period.The study period was between january 2012 to december 2017.Abouzeid et al.(2021).Multidisciplinary management of juvenile nasopharyngeal angiofibroma.The egyptian journal of neurology, psychiatry and neurosurgery, 57(167).Doi.Org/10.1186/s41983-021-00414-0.

• Brand Name: CONTOUR
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14961465
• MDR Text Key: 295598815
• Report Number: 2134265-2022-07764
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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?: No
• Date Manufacturer Received: 07/22/2022
• 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): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male