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

Device Problem Entrapment of Device (1212)

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

Event Date 08/01/2007

Event Type  malfunction  

Manufacturer Narrative

Weber, w., kis, b., siekmann, r., jans, p., laumer, r., <(>&<)> kühne, d.(2007).Preoperative embolization of intracranial arteriovenous malformations with onyx.Neurosurgery, 61(2), 244-254.Doi:10.1227/01.Neu.0000255473.60505.84 the onyx will not be returned for evaluation as it remains in the patient.The onyx model and lot numbers were not provided.The article provided limited information on these events.A cause for the reported stuck microcatheter during onyx embolization could not be conclusively determined.Mdrs related to this article: 2029214-2017-00810 and 2029214-2017-00811.

Event Description

Medtronic literature review found reports of stuck microcatheters during onyx embolization procedures.The purpose of this article was to present the authors¿ experience in the treatment of intracranial arteriovenous malformations (avms) using onyx embolization and neurosurgical resection.The authors treated 47 patients with 47 avms; mean patient age was 36 years; 31 were male and 16 were female.Additional embolic material (liquid coils, nbca, etc.) was used in 19 patients.The article states that periprocedurally, four ¿stuck microcatheters¿ without clinical deficits were encountered.

• 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 ; 9496801224
• MDR Report Key: 6655421
• MDR Text Key: 78106907
• Report Number: 2029214-2017-00809
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030004
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 05/22/2017
• Initial Date FDA Received: 06/20/2017
• 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