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

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

Patient Problems Fistula (1862); Unspecified Tissue Injury (4559)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Tavakkoli, armin, et al."intra-operative emergence of occult dural arteriovenous fistula after middle meningeal artery embolization for chronic subdural hematoma: case report and literature review." radiology case reports 17.5 (2022): 1470-1474.

Event Description

It was reported via a journal article that a fistulae occurred following embolization.Abstract: dural arteriovenous fistulae of the middle meningeal artery (mma-davf) are high risk lesions that can lead to intracranial hemorrhage.We describe the case of an adult male that presented with chronic subdural hematomas and was treated with burr hole craniotomy plus middle meningeal artery (mma) embolization.Although the pre-embolization angiogram showed no signs of a fistula, a fistula arising from the mma and draining into the superior sagittal sinus emerged intra-operatively.To our knowledge, this is the first case of intra-operative emergence of occult mma-davf with intracranial drainage during mma embolization for chronic subdural hematoma treatment.This observation supports monitoring for and embolizing spontaneous mma-davf following mma embolization.A chronically ill-appearing adult male presented to our emergency department after sustaining a fall from standing.Past medical history was significant for laryngeal cancer status post total laryngectomy.There was no history of antiplatelet or anticoagulation medication.A non-contrast computed tomography scan showed bilateral 15mm mixed density csdh without midline shift ( figs.1 a and b).The patient was neurologically intact without symptoms of elevated intracranial pressure, and he wished to avoid surgical drainage unless absolutely necessary.Surgical drainage was therefore deferred and enrollment in our active mma embolization trial for treatment of csdh was offered.The patient declined all intervention preferring close outpatient follow up.Un- fortunately, a month later the patient re-presented to our emergency department after sustaining another fall.A head computed tomography showed significant interval enlargement of the right csdh measuring up to 3cm with 1cm of mid- line shift and a much smaller left csdh measuring up to 4mm ( figs.1 c and d).He was alert but had mild left sided weakness.Surgical drainage was once again offered and this time he and his family agreed to proceed.The patient underwent right burr hole craniotomy for evacuation of csdh with subdural drain placement.He regained full strength in all extremities and the subdural drain was removed on post-operative day 2.Subsequently, the patient was again offered participation in our active mma embolization trial (clinicaltrials.Gov, id: (b)(4)).He accepted, was randomized to the intervention group, and underwent mma embolization on post-operative day 5.The patient was placed under general anesthesia and the right internal and external carotid arteries were sequentially accessed via the right radial artery.A biplane angiogram of the external carotid artery and mma showed no evidence of pre-operative davf ( fig.2 a).Following the initial infusions of 250-micron embozene particles, a repeat microcatheter angiogram showed new arteriovenous shunting from one of the distal branches of the mma ( figs.2 b and c).The mma-davf was subsequently embolized with 500-micron particles.Complete stasis of the mma-davf was achieved ( fig.2 d).

Manufacturer Narrative

Correction - h6 patient codes: updated from fistula e2314 to unspecified tissue injury e2015.E1 - initial reporter facility name: (b)(6).Tavakkoli, armin, et al."intra-operative emergence of occult dural arteriovenous fistula after middle meningeal artery embolization for chronic subdural hematoma: case report and literature review." radiology case reports 17.5 (2022): 1470-1474.

Event Description

It was reported via a journal article that tissue damage occurred following embolization.Abstract: dural arteriovenous fistulae of the middle meningeal artery (mma-davf) are high risk lesions that can lead to intracranial hemorrhage.We describe the case of an adult male that presented with chronic subdural hematomas and was treated with burr hole craniotomy plus middle meningeal artery (mma) embolization.Although the pre-embolization angiogram showed no signs of a fistula, a fistula arising from the mma and draining into the superior sagittal sinus emerged intra-operatively.To our knowledge, this is the first case of intra-operative emergence of occult mma-davf with intracranial drainage during mma embolization for chronic subdural hematoma treatment.This observation supports monitoring for and embolizing spontaneous mma-davf following mma embolization.A chronically ill-appearing adult male presented to our emergency department after sustaining a fall from standing.Past medical history was significant for laryngeal cancer status post total laryngectomy.There was no history of antiplatelet or anticoagulation medication.A non-contrast computed tomography scan showed bilateral 15mm mixed density csdh without midline shift ( figs.1 a and b).The patient was neurologically intact without symptoms of elevated intracranial pressure, and he wished to avoid surgical drainage unless absolutely necessary.Surgical drainage was therefore deferred and enrollment in our active mma embolization trial for treatment of csdh was offered.The patient declined all intervention preferring close outpatient follow up.Un- fortunately, a month later the patient re-presented to our emergency department after sustaining another fall.A head computed tomography showed significant interval enlargement of the right csdh measuring up to 3cm with 1cm of mid- line shift and a much smaller left csdh measuring up to 4mm ( figs.1 c and d).He was alert but had mild left sided weakness.Surgical drainage was once again offered and this time he and his family agreed to proceed.The patient underwent right burr hole craniotomy for evacuation of csdh with subdural drain placement.He regained full strength in all extremities and the subdural drain was removed on post-operative day 2.Subsequently, the patient was again offered participation in our active mma embolization trial (b)(6).He accepted, was randomized to the intervention group, and underwent mma embolization on post-operative day 5.The patient was placed under general anesthesia and the right internal and external carotid arteries were sequentially accessed via the right radial artery.A biplane angiogram of the external carotid artery and mma showed no evidence of pre-operative davf ( fig.2 a).Following the initial infusions of 250-micron embozene particles, a repeat microcatheter angiogram showed new arteriovenous shunting from one of the distal branches of the mma ( figs.2 b and c).The mma-davf was subsequently embolized with 500-micron particles.Complete stasis of the mma-davf was achieved ( fig.2 d).

• 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: 15102279
• MDR Text Key: 296568964
• Report Number: 2134265-2022-08151
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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: 08/01/2022
• 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 Sex: Male