MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035433040
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Premature Activation (1484)
Health Effect - Clinical Codes	Hemorrhage, Cerebral (1889); Paralysis (1997)
Date of Event	06/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The subject device is not available.
Event or Problem Description
It was reported that during the procedure, the coil (subject device) prematurely detached within the patient.The physician was able to retrieve the coil using an unspecified type of retriever.During an angiography, a second part of the coil was reported to be broke inside the guide catheter and migrated into the patientm2-m3 segment.The physician was able again to retrieve the second part of the broken coil using an unspecified type of retriever.After magnet resonance control, the patient experienced bleeding on the left hemisphere and an unspecified type of surgery was performed to drain the bleeding.The patient is reported to have hemiparesis.No further information is available.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available indicated that the patient's anatomy was noted to be moderately tortuous and the coil was repositioned 2-3 times.It is likely that these procedural factors may have contributed to the reported event; however, this cannot be determined.Based on the information available the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that during the procedure, the coil (subject device) prematurely detached within the patient.The physician was able to retrieve the coil using an unspecified type of retriever.During an angiography, a second part of the coil was reported to be broke inside the guide catheter and migrated into the patient¿s m2-m3 segment.The physician was able again to retrieve the second part of the broken coil using an unspecified type of retriever.After magnet resonance control, the patient experienced bleeding on the left hemisphere and an unspecified type of surgery was performed to drain the bleeding.The patient is reported to have hemiparesis.No further information is available.

• Brand Name: TARGET HELICAL ULTRA 3 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5823346
• Report Number: 3008881809-2016-00096
• Device Sequence Number: 16451357
• Product Code: HCG
• UDI-Device Identifier: 04546540676061
• UDI-Public: (01)04546540676061(17)190131(10)18829717
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: M0035433040
• Device Lot Number: 18829717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 12/12/2016
• 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; Required Intervention
• Patient Age: 46 YR