MAUDE Adverse Event Report: COVIDIEN (IRVINE) ONYX; AGENT, INJECTABLE, EMBOLIC

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

The liquid embolic material was not returned for analysis as it was consumed in the procedures.Attempts to gather additional information were made, however, our attempts were unsuccessful.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Unintended vessel occlusion and neurological deterioration are known inherent risks of endovascular procedure and are documented in our device¿s instruction for use (ifu).The exact cause remains unknown.Per the onyx instructions for use (ifu): ¿ do not allow more than 1 cm of onyx¿ les to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx reflux, or prolonged injection time may result in difficult catheter removal and catheter entrapment.Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage.The long-term effects of an entrapped catheter that is left in a patient is unknown, but could potentially include clot formation, infection or catheter migration.Difficult catheter removal or catheter entrapment may be caused by one or more of the following factors: ¿ long catheterization time ¿ angio-architecture: very distal arteriovenous malformation fed by afferent, lengthened, small, or tortuous pedicles ¿ vasospasm ¿ reflux ¿ injection time.To reduce the risk of catheter entrapment, carefully select catheter placement and manage reflux to minimize the factors listed above.Onyx¿ les reflux along the distal tip of the micro catheter: apart from the risk of ischemic complications due to unintended embolization, significant reflux may result in entrapment of the micro catheter causing difficult removal.The amount of reflux that can be accepted must always be compared to the angioarchitecture of the malformation to minimize risk of unintended embolization or difficult catheter removal.In general, minimize the reflux to less than 1 cm along the distal tip of the micro catheter.All other factors may affect this limit.¿ should catheter removal become difficult, the following technique may assist in catheter retrieval: ¿ carefully pull the catheter to assess any resistance to removal.¿ if resistance is felt, remove any ¿slack¿ in the catheter.¿ gently apply traction to the catheter (approximately 3-4 cm of stretch to the catheter).¿ hold this traction for a few seconds and release.Assess traction on vasculature to minimize risk of hemorrhage.¿ this process can be repeated intermittently until catheter is retrieved.¿ when using ev3 micro catheters, do not apply more than 20 cm of traction to catheter, to minimize risk of catheter separation.¿ for entrapped catheters: ¿ under some difficult clinical situations, it may be safer to leave a flow-directed catheter in the vascular system, rather than risk rupturing the malformation and, consequently a hemorrhage, by exercising too much traction on an entrapped catheter.¿ this is accomplished by stretching the catheter and cutting the shaft near the entry point of vascular access allowing the catheter to remain in the artery.¿ if catheter breaks during removal, distal migration or coiling of the catheter may occur.¿ same day surgical resection should be considered to minimize risk of thrombosis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report through literature review of "endovascular treatment of dural arteriovenous fistulas using transarterial liquid embolization in combination with transvenous balloon-assisted protection of the venous sinus".The average patient ages were 55 (¿ or +15 years) and 11 males and 11 females.22 patients diagnosed with dural arteriovenous fistula (davfs) who were treated with endovascular transarterial liquid embolization in combination with transvenous balloon-assisted protection of the venous sinus.All these patients were symptomatic (tinnitus; ocular symptoms; headache; and other symptoms and one patient presented with an intracerebral hemorrhage.Five procedure-related complications occurred, resulting in an overall complication.2 small infarctions, 2 small subdural hemorrhages (most likely caused by vessel perforation during navigation of the microcatheter into the respective arterial feeder or during traction of the microcatheter after embolization), and 1 small intracerebral hemorrhage (1 cm in diameter).In 1 patient with a small venous infarction, inadvertent embolization of the proximal part of the vein of labbe´ could be identified as a suspected reason for the complication.For the small intracerebral hemorrhage, which was detected on a peri-interventional conebeam ct scan during the treatment of a patient with a cognard iia/ borden i davf, stasis in a small temporal vein, caused by the temporary balloon occlusion, could be identified as a suspected reason for the complication.Three complications were asymptomatic, and 2 complications were symptomatic.The 2 patients with symptomatic complications had heada ches, which were declining until discharge and no longer present 6 months after treatment.No complication with permanent neurologic deficits was recorded.No procedure-related cranial neuropathies were observed.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 8116038
• MDR Text Key: 128787651
• Report Number: 2029214-2018-00995
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H060003
• 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
• Report Date: 11/29/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/29/2018
• 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): Other