MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aneurysm (1708); Rupture (2208)

Event Date 11/26/2016

Event Type  Injury  

Manufacturer Narrative

The literature article involves 94 patients, in two cases procedural aneurysm rupture developed.This is event 2 of 2 the exact date of the adverse event is unknown.All patients were treated between june/2011 and sep/2013.The subject device is not available.

Event Description

In a retrospective literature review for interference phenomenon of microcatheters in the jailing treatment with internal carotid artery (ica) side wall aneurysms with an open cell stent system.The techniques used two microcatheters; one was navigated to the target aneurysm for coiling (subject device) and the other was used as a stent transfer microcatheter.The technique was applied to 94 patients, in two cases procedural aneurysm rupture developed.The ruptures were stopped by further packing of coils.No other procedural complications were observed and none of the cases resulted in any neurological deficits at discharge.

Manufacturer Narrative

A review of the device history record could not be performed because the lot number was not reported.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, the reported patient aneurysm rupture is a known risk associated with endovascular procedures and is noted as such in the device direction for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

In a retrospective literature review for interference phenomenon of microcatheters in the jailing treatment with internal carotid artery (ica) side wall aneurysms with an open cell stent system.The techniques used two microcatheters; one was navigated to the target aneurysm for coiling (subject device) and the other was used as a stent transfer microcatheter.The technique was applied to 94 patients, in two cases procedural aneurysm rupture developed.The ruptures were stopped by further packing of coils.No other procedural complications were observed and none of the cases resulted in any neurological deficits at discharge.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6523717
• MDR Text Key: 73762550
• Report Number: 3008881809-2017-00130
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K013789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DETACHABLE COILS (UNKNOWN); NEUROFORM EZ (STRYKER)
• Patient Age: 57 YR