MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX - PLATINUM MICROCOIL; CNV DCS COILS

Catalog Number DMX18041520

Device Problems Difficult To Position (1467); Premature Activation (1484); Stretched (1601); Extrusion (2934)

Patient Problem Weakness (2145)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

This one of two initial/final mdr report being submitted for this complaint with the associated mfr report 1226348-2016-00113 (b)(4) concomitant medical products: stryker sl-10 microcatheter; penumbra benchmark guide.071¿ wire; stryker xt-27 microcatheter; stryker neuroform stent; stryker transcend ex platinum wire 205cm; synchro 14 wire.The deltamaxx will not be returned, therefore the root cause of the coil unable to be deployed fully inside the target site, the coil becoming ensnared on a competitors stent , its stretching, its unintended detachment, its protrusion into the parent vessel, and the patients stroke cannot be determined.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Neurologic deficits, specifically stroke symptoms of weakness, are known potential adverse events associated with the use of the codman cnv interventional devices.Positioning difficulty, premature detachment, protrusion into the parent vessel and unraveled/stretched are known potential product failures associated with the codman embolic oils.Deployment difficulty with inaccurate placement and inadequate radiopacity are known potential product failures associated with the use of the enterprise device.Resistance/friction is a known product failure associated with the codman microcatheter devices.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests that patient anatomy, target lesion characteristics, device interaction and intraprocedural issues may have contributed to the reported events.There is no need for further action at this time.

Event Description

As reported by a health care professional, patient present with left sided stroke symptoms upon awakening post procedure.Pre-procedure angiography revealed a right posterior communicating (p-comm) artery to have a wide neck, however on the lateral view showed a narrower neck.The patient did not have any symptoms pre-procedure and was reported to have medium level of vessel tortuosity.The aneurysm had 5.80 x 3.40 dimension and was complex cone shaped.Index procedure was performed on (b)(6) 2016, the physician decided to coil the aneurysm with a deltamaxx coil 4x15 (dmx18041520/p11550) without stent assist.A competitor's sl-10 microcatheter was inserted through a competitor's.071" guide catheter to the right pcomm.The deltamaxx 4x15 coil was inserted through the microcatheter and the physician attempted to embolize the right pcomm but was unsuccessful due to wide neck of aneurysm.The deltamaxx coil was successfully resheathed and removed; microcatheter remained in the right p-comm.Another xt-27 microcatheter (competitor's was inserted through the benchmark guide into the right internal carotid distal to the right pcomm aneurysm and a 4.5 x 15mm competitor's stent was successfully delivered over the neck of the right pcomm aneurysm.The xt-27 microcatheter was removed as the sl-10 microcatheter was now stented over and trapped into the right pcomm aneurysm.The physician decided to reinsert the deltamaxx coil 4x15 back through the sl-10 microcatheter to embolize the right pcomm.The coil successfully embolized into the right pcomm but there was 4cm of coil that still needed to be inserted and while manipulating the coil the sl-10 microcatheter pushed out of the aneurysm.The physician attempted to reinsert the sl-10 microcatheter over the deltamaxx coil, however during the reinsertion attempt the deltamaxx coil became ensnared upon the "open" cell strut of the competitor's stent causing the deltamaxx coil to stretch.Further manipulation caused the coil to detach from the deltamaxx pusher wire segment.The deltamaxx coil pusher was removed successfully and discarded and the deltamaxx coil remained stretched within the sl-10 microcatheter.Using a competitor's ex platinum wire 205cm, the stretched coil within sl-10 microcatheter was successfully pushed out of catheter into the lumen of the competitor's stent 4.0x15 and remainder of the stretched coil was in the right internal carotid proximal to the competitor's stent.The sl-10 microcatheter was removed.The physician decided to insert a prowler select plus microcatheter (606s255x/lot unknown) and place an enterprise stent 4.5x37 (enf453712/10485322) through the implanted competitor's stent 4.0x15 to trap the stretched deltamaxx coil against the competitor's stent and proximal to the stent in the lumen of the right internal carotid.The prowler select plus had difficulty traversing the lumen of the neuroform stent, but did get distal before deployment of the enterprise stent 4.5x37.The enterprise deployment fell short of the neuroform stent as there was not good visualization of the distal marker lines.Intended landing target of enterprise stent 4.5x37 was unsuccessful, the stent landed proximal to neurform stent 4.0x15) in internal carotid artery.Proximal to pcomm aneurysm.Pt.Was with stable vitals throughout the procedure, but upon awakening post procedure, patient was noted with left sided weakness and deficit.The following morning on (b)(6) 2016, pt.Deficit still unchanged.On (b)(6) 2016 the physician deployed another neuroform stent 4.5x30 across the initial neuroform 4.0x15 stent implant in hopes of tacking the stretched deltamaxx coil against the right internal carotid artery.There will be no codman neuro product used being sent back for analysis.

• Brand Name: DELTAMAXX - PLATINUM MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 5759925
• MDR Text Key: 48503439
• Report Number: 2954740-2016-00134
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: DMX18041520
• Device Lot Number: P11550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR