MAUDE Adverse Event Report: COVIDIEN (IRVINE) AXIUM; DEVICE, EMBOLIZATION, VASCULAR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Seizures (2063); Stenosis (2263); Respiratory Failure (2484)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Attempts have been made to gather additional details; 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.Neurological deterioration is known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report through literature review of mittal s, singh v, phadke rv, neyaz z.Endovascular treatment of ruptured pica aneurysms and association with its extradural origin: a single-center experience.Indian j radiol imaging 2018; 28: 232-8.11 patients (8 females, 3 males; mean age: 40.1 years, range: 22-62 years) presented with acute onset severe headache and non-contra st-enhanced computed tomography (ncct)-documented subarachnoid hemorrhage (sah) and intraventricular hemorrhage (ivh).A (b)(6) female was treated for a fuso-saccular aneurysm at the junction of va-pica on rt side managed with coiling.Pica was seen post coiling.Follow-up mra at 3 and 6 months; shows narrowing of proximal pica and no e/o (evidence of) aneurysm.Narrowed proximal pica.Distal portion is normal.Out of 11 patients, 10 patients had no neurological deficit post-procedure and 1 patient had a post procedural complication as the patient was hunt and hess grade 4 and developed seizures following which her condition deteriorated and was put on ventilator support.Imaging showed obstructive hydrocephalus, which was managed with a ventricular peritoneal (vp) shunt.Long-term follow-up (3 years) showed mrs grade 2.Ancillary devices: echelon 10, axium coils, evory, and hyperform.

• Brand Name: AXIUM
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8297354
• MDR Text Key: 134748729
• Report Number: 2029214-2019-00070
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• 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: 01/07/2019
• 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