MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036181040

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

Patient Problem Perforation of Vessels (2135)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.

Event Description

It was reported that the subject device perforated the vessel during coil embolization procedure of major aortopulmonary collateral arteries (mapca).The physician used the subject device and additional coils to continue coiling and resolve the vessel perforation.There were no reported clinical consequences to the patient.

Manufacturer Narrative

The device history record review could not be performed since the lot number was not known.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.As the device was not returned, the exact cause for the difficulties encountered with the device cannot be definitively determined.However, vessel perforation is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu); therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that the subject device perforated the vessel during coil embolization procedure of major aortopulmonary collateral arteries (mapca).The physician used the subject device and additional coils to continue coiling and resolve the vessel perforation.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XXL 360 10MM X 40CM
• 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: 7150123
• MDR Text Key: 95896763
• Report Number: 3008881809-2017-00550
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K161429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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: 04/30/2020
• Device Catalogue Number: M0036181040
• Device Lot Number: 19679421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 3 YR