MAUDE Adverse Event Report: MEDTRONIC COVIDIEN ONYX 18 KIT PACKAGED A VM AND TUMOR; 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 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

The onyx was implanted in the patient and no product has been returned for evaluation.The event could not be confirmed and an event cause could not be determined from the reported information.Mdrs related to this event: 2029214-2016-00563 2029214-2016-00564 2029214-2016-00565 2029214-2016-00566 2029214-2016-00567 2029214-2016-00568 2029214-2016-00569 2029214-2016-00570 2029214-2016-00571 2029214-2016-00572 2029214-2016-00573 2029214-2016-00574 2029214-2016-00575.

Event Description

Medtronic received report of microcatheter separation during use of onyx liquid embolic.The patient was undergoing onyx embolization of an arteriovenous fistula in the left and right middle cerebral artery.It was reported that onyx was placed and the physician planned to remove the microcatheter, but found that the microcatheter was ruptured.The "head" part of microcatheter became stuck in blood vessels of patient.It was reported that the procedure was continued and completed successfully.The patient's status was stable.

Manufacturer Narrative

Based on the reported information the customer¿s report of catheter ¿rupture¿ was confirmed to be catheter ¿separation¿.Onyx residue was found within the hub of all three marathon microcatheters.In addition, the returned marathon microcatheters were found to be occluded with onyx.The catheters were also found stretched and separated.The tubing material at the distal separated end of the catheters exhibited with stretching and necking which suggest that the catheters separated when exceeding the tensile strength of the tubing material.The separation likely resulted from tensile failure of the catheters during extraction from the treatment site due to the reported entrapment.Therefore the catheter separation was likely a result of being pulled beyond the 20cm limit noted in the instructions for use (ifu).Per the marathon flow directed micro catheter ifu (instructions for use): ¿note: do not apply more than 20 cm of traction to catheter to minimize risk of catheter separation.However, the definitive cause for the catheter ¿entrapment¿ could not be confirmed.The lot history record review of the marathon reported lot number showed no discrepancies that would have contributed to the reported experience.All products are 100% inspected for damages and irregularities during manufacture.In addition, there is no evidence suggesting that the onyx was defective.Per the onyx ifu: ¿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.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.

Manufacturer Narrative

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

• Brand Name: ONYX 18 KIT PACKAGED A VM AND TUMOR
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5788620
• MDR Text Key: 49391000
• Report Number: 2029214-2016-00566
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2016

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 Expiration Date: 07/21/2017
• Device Model Number: 105-7000-060
• Device Lot Number: A143381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided; 06/15/2016
• Supplement Dates FDA Received: 12/02/2016; 09/24/2017
• Date Device Manufactured: 08/06/2015
• 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
• Patient Age: 54 YR