MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4 MM X 15 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035434150

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

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

Event Date 01/16/2014

Event Type  Injury  

Event Description

It was reported that approximately one year follow up visit, aneurysm recanalization was found and re-embolization was performed in response to the finding.The patient recovered without clinical consequences.

Manufacturer Narrative

The subject device remains implanted; therefore, physical analysis cannot be performed.The device history record review confirms that the device met all material, assembly and performance specification.From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse.However, medical intervention related to aneurysm re-embolization is a known risk associated with endovascular procedures and is noted in the device direction¿s for use (dfu).Therefore, a root cause of anticipated procedural complication has been assigned to this event.Subject device remained implanted.

• Brand Name: TARGET HELICAL ULTRA 4 MM X 15 CM
• 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: 4341066
• MDR Text Key: 19345567
• Report Number: 3008853977-2014-00400
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112385
• 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: 11/26/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: M0035434150
• Device Lot Number: 15684815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• 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: M0035424080 TARGET 360 ULTRA 4MM X 8CM (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR