MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 4MM X 7MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SSC04070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Hemorrhage, Cerebral (1889); Perforation of Vessels (2135); Rupture (2208)
Date of Event	11/11/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is the first of 2 reports.Subject device is not available.
Event or Problem Description
It was reported that during coil embolization of a left internal carotid artery (ica) unruptured aneurysm, after placing a first coil uneventfully in the aneurysm, ¿the physician was not sure if the coil was herniating into the vessel¿.Medical intervention with an occlusion balloon catheter (subject device) was performed in order to push back the herniated coil part into the aneurysm.The physician inflated the balloon for 30 seconds and the distal ica or the aneurysm ruptured leading to hemorrhage.Blood flow distal to the ruptured was blocked.The patient expired due to bleeding.The physician stated that the vessel rupture was related to the balloon inflation and the patient death was related to the balloon inflation and the patient¿s vasculature.
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.However, patient vessel perforation, patient death, patient hemorrhage, patient aneurysm burst are known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that during coil embolization of a left internal carotid artery (ica) unruptured aneurysm, after placing a first coil uneventfully in the aneurysm, ¿the physician was not sure if the coil was herniating into the vessel¿.Medical intervention with an occlusion balloon catheter (subject device) was performed in order to push back the herniated coil part into the aneurysm.The physician inflated the balloon for 30 seconds and the distal ica or the aneurysm ruptured leading to hemorrhage.Blood flow distal to the ruptured was blocked.The patient expired due to bleeding.The physician stated that the vessel rupture was related to the balloon inflation and the patient death was related to the balloon inflation and the patient¿s vasculature.

• Brand Name: TRANSFORM SUPER COMPLIANT 4MM X 7MM
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6149801
• Report Number: 3008881809-2016-00293
• Device Sequence Number: 13672325
• Product Code: MJN
• UDI-Device Identifier: 07613327004694
• UDI-Public: (01)07613327004694(17)180531(10)19072511
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: M003SSC04070
• Device Lot Number: 19072511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TARGET COIL (STRYKER)
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 58 YR