MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035452060

Device Problems Material Protrusion/Extrusion (2979); Premature Separation (4045)

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

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

Device implanted.

Event Description

It was reported that during coil embolization procedure, the physician pulled back the subject coil and the main coil prematurely detached.Half of the coil remained in the aneurysm while the other half protruded, making a tail on the patient¿s vessel.The physician deployed a stent to prevent the protruded coil from blocking the patient¿s vessel.There were no clinical consequences to the patient reported.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint it is possible that the main coil prematurely detached and later protruded while getting pulled back due to some procedural factors encountered during use, possible leading to the as reported issues 'nv - main coil protrusion' and ' nv - main coil prematurely detached separated inside patient'; however, cannot be conclusively determined.The additional information provided by the customer indicated that no damage was noted to the device prior to use and the device was prepared as per direction for use (dfu).An assignable cause of undetermined was assigned to the as reported issues 'nv - main coil protrusion' and ' nv - main coil prematurely detached separated inside patient' as the device was not returned and the review and analysis of all available information failed to indicate as assignable cause.

Event Description

It was reported that during coil embolization procedure, the physician pulled back the subject coil and the main coil prematurely detached.Half of the coil remained in the aneurysm while the other half protruded, making a tail on the patient¿s vessel.The physician deployed a stent to prevent the protruded coil from blocking the patient¿s vessel.There were no clinical consequences to the patient reported.

• Brand Name: TARGET HELICAL NANO 2 MM X 6 CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7858115
• MDR Text Key: 119640859
• Report Number: 3008881809-2018-00391
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: 07613252600381
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

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: 04/07/2021
• Device Catalogue Number: M0035452060
• Device Lot Number: 20399150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL-10 MICROCATHETER (STRYKER)
• Patient Outcome(s): Required Intervention