MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK MATRIX2 ULTRASOFT SR 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M003497520SR0
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device remains implanted.
Event or Problem Description
It was reported that during a coil embolization of a ruptured aneurysm at the internal carotid artery (ica) siphon segment (shape was near round and diameter approximately 10 mm) with the subject coil, the coil was partially implanted about 1/3 of the length into the aneurysm.During repositioning, the coil detached and dropped into the parent artery.After failed attempt to withdraw the detached piece of coil by withdrawing the delivery wire slowly and smoothly, the operator decided to ¿deploy¿ the coil and continued to insert the next coil.Under digital subtraction angiography (dsa), it was observed that the artery looked good so the procedure was finished.The patient condition was good.
Additional 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, physical as well as a functional testing could not be performed.Based on additional information received, the operator was "adjusting the coil¿ /repositioning the coil for about 20 seconds.It is probable that the coil was prematurely detached during the re-positioning attempt causing the as reported event.Therefore, an assignable cause of operational context was assigned to this event.
Event or Problem Description
It was reported that during a coil embolization of a ruptured aneurysm at the internal carotid artery (ica) siphon segment (shape was near round and diameter approximately 10 mm) with the subject coil, the coil was partially implanted about 1/3 of the length into the aneurysm.During repositioning, the coil detached and dropped into the parent artery.After failed attempt to withdraw the detached piece of coil by withdrawing the delivery wire slowly and smoothly, the operator decided to ¿deploy¿ the coil and continued to insert the next coil.Under digital subtraction angiography (dsa), it was observed that the artery looked good so the procedure was finished.The patient condition was good.

• Brand Name: MATRIX2 ULTRASOFT SR 5MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6251248
• Report Number: 3008881809-2017-00016
• Device Sequence Number: 914276
• Product Code: HCG
• UDI-Device Identifier: 04546540691774
• UDI-Public: (01)04546540691774(17)190531(10)19149233
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K050700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: M003497520SR0
• Device Lot Number: 19149233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 64