MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035476150

Device Problems Break (1069); Migration or Expulsion of Device (1395)

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

Event Date 11/19/2014

Event Type  Injury  

Event Description

It was reported that the physician placed a half of the subject coil inside the aneurysm and decided to adjust the coil position.However, during maneuvering and repositioning of the coil, it broke resulting in a half of the coil protruding into the parent vessel.A snare was successfully used to remove the coil.The procedure was completed with another of the same device and there was no clinical consequence to the patient.

Manufacturer Narrative

The device is not available to the manufacturer.

• Brand Name: TARGET 360 SOFT 6MM X15CM
• 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: alyson harris ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 4318355
• MDR Text Key: 5208795
• Report Number: 3008853977-2014-00387
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2014

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 Catalogue Number: M0035476150
• Device Lot Number: 17622280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/10/2014
• 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: NEUROFORM 3 EZ STENT SYSTEM (STRYKER); ECHELON-10 MICROCATHETER(EV3); TWO TARGET COILS (STRYKER)
• Patient Outcome(s): Required Intervention