MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage, Subarachnoid (1893); Dysphasia (2195); Ptosis (2620)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

The device remains implanted.

Event Description

It was reported that the microcatheter was pushed out of the left ophthalmic internal carotid artery (ica) aneurysm during the delivery of a coil resulting in the distal end of the coil becoming stuck between the subject ¿intra-aneurysmal coil-ball¿.The physician was unable to retrieve the coil and the coil was stretched.The physician pulled back the microcatheter with the coil inside, placed a stent that covered the coil at the level of the ica bifurcation and detached the coil.Post procedure, after the extubation the patient had an aphasia and left ptosis.The magnetic resonance angiogram (mra) showed a left subarachnoid hemorrhage.There was no treatment administered but it was reported that 11 days post procedure adverse events were resolved without sequelae.The physician stated that the adverse events were not related to the ¿stretching coil¿ but it was related to the maneuver necessary to deliver other devices.

Manufacturer Narrative

The main coil appears to have got tangled in the previously placed coils in the aneurysm and stretched during an attempt to retrieve the device.The patient complications (hemorrhage, stroke and subsequent neurological deficits) although anticipated in nature, are likely to have occurred, in part as a result of the damage sustained to the subject coil.An assignable cause of operational context has been assigned to this complaint as some procedural factors encountered during the procedure limited the performance of the device contributed to the reported event.

Event Description

It was reported that the microcatheter was pushed out of the left ophthalmic internal carotid artery (ica) aneurysm during the delivery of a coil resulting in the distal end of the coil becoming stuck between the subject ¿intra-aneurysmal coil-ball.¿ the physician was unable to retrieve the coil and the coil was stretched.The physician pulled back the microcatheter with the coil inside, placed a stent that covered the coil at the level of the ica bifurcation and detached the coil.Post procedure, after the extubation the patient had an aphasia and left ptosis.The magnetic resonance angiogram (mra) showed a left subarachnoid hemorrhage.There was no treatment administered but it was reported that 11 days post procedure adverse events were resolved without sequelae.The physician stated that the adverse events were not related to the ¿stretching coil¿ but it was related to the maneuver necessary to deliver other devices.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6003888
• MDR Text Key: 56594623
• Report Number: 3008881809-2016-00203
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.27¿¿ MICROCATHER (UNKNOWN MANUFACTURER); DERIVO® FLOW DIVERTER (ACANDIS (B)(4)); EXCELSIOR SL-10 MICROCATHETER (STRYKER); TARGET COIL (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR