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 Confusion/ Disorientation (2553); Ischemia Stroke (4418)

Event Date 01/01/2009

Event Type  Injury  

Event Description

It was reported via journal article that patient complications occurred.The patient underwent angiogram and embolization for glomus tympanicum tumour.Otoscopy revealed a red, smooth, pulsatile lesion behind the tympanic membrane.Computed tomography (ct) and magnetic resonance imaging (mri) scan confirmed the presence of a small soft tissue mass in the left middle ear cavity inferior to the middle ear ossicles consistent with glomus tympanicum tumor.A diagnostic angiogram was performed to evaluate the vascular anatomy and the feeder of the glomus tumour.Selective left ascending pharyngeal angiography showed an intense tumoral blush in the left petrous temporal bone region being fed by the inferior tympanic artery, a branch of neuromeningeal division of the apa.Selective cannulation of the inferior tympanic artery was achieved by the coaxial microcatheter system.The glomus tympanicum tumor was embolized using contour pva particles of 150-250 um.At the end of the particulate injection the patient became disorientated and confused, neurological examination was otherwise unremarkable.The check angiogram showed near total de-vascularization of the tumor and filling of the left vertebral artery through an anastomotic channel between the left ascending pharyngeal artery and the vertebrobasilar artery.Immediate post embolization ct was normal.Mri performed five days later showed a focal wedge-shaped infarct in the right medial and inferior cerebellar hemisphere and multiple small hyperintense foci in the bilateral posterior cerebral artery territory, temporal-occipital lobes and thalami.The appearance was consistent with a reflux of particles in the posterior circulation.The patient made a good clinical recovery following posterior circulation stroke in six weeks and was successfully operated for the glomus tumor.

Manufacturer Narrative

Date of event: no date provided, used the first date of the year provided.V.Sawlani, s.Browning, i.M.Sawhney, r.Redfern, posterior circulation stroke following embolization of glomus tympanicum - relevance of anatomy and anastomoses of ascending pharyngeal artery, interventional neuroradiology 15: 229-236, 2009.

• 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; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15089456
• MDR Text Key: 296464862
• Report Number: 2134265-2022-07974
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA 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): Other
• Patient Age: 60 YR
• Patient Sex: Female