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

Model Number 105-7000-060

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2014

Event Type  Injury  

Manufacturer Narrative

The onyx was not returned for analysis; therefore the complaint could not be confirmed, and the event cause could not be determined.The lot history record review was not possible since the lot number was not reported.Mdr 2 of 2 this mdr is for the onyx 34 used in the procedure.Please reference mdr 2029214-2016-00791 for the onyx 18 used in this procedure.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a competitor's catheter was found stuck, broken, and occluded with a relationship to the onyx during an embolization procedure of a dural arteriovenous fistula (davf).Under general anesthesia, the right femoral artery was punctured with short 6f introducer sheath.Catheterization of the left common artery using a vertebral catheter was completed, confirming persistence of the fistula without any significant change.The physician used a competitor's microcatheter with a 25 mm detachable tip on a hybrid microguide catheter, allowing distal catheterization of the squamous branch of the left middle meningeal artery.The physician injected 2.4 ml of onyx 18 followed by 1 ml of onyx 34 enabling the embolization of the suspended segment of the sigmoid sinus by filling the dural venous collectors as well as the extremities of the various arterial branches feeding this fistula.The final check showed an exclusion of the fistula.The microcatheter was stretched during removal, and it remained attached to the sheath.As a result, a microsnare-kit had to be used to recover it.There was no patient complication reported during this procedure.Per core lab review the microcatheter was stuck, broken, and occluded with onyx.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ONYX AVM
• 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 ; 9496801224
• MDR Report Key: 5934540
• MDR Text Key: 54141585
• Report Number: 2029214-2016-00792
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

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
• Device Model Number: 105-7000-060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: 03/07/2016
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 62 YR