MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during coil embolization of an aneurysm located on the internal carotid artery-posterior communicating artery (ic-pc), there was difficulty repositioning the 7th coil (subject device) in the aneurysm.After three attempts, the subject coil was stuck and could not be moved when retrieving a little the microcatheter.A balloon catheter was inflated at the neck of the aneurysm to hold the implanted coils in aneurysm so that the subject coil could be retrieved with the microcatheter.The physician confirmed after procedure that the tip of the microcatheter was deformed.The subject coil was mechanical detached after removal from the patient ¿s body.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during coil embolization of an aneurysm located on the internal carotid artery-posterior communicating artery (ic-pc), there was difficulty re-positioning the 7th coil (subject device) in the aneurysm.After three attempts, the subject coil was stuck and could not be moved when retrieving a little the microcatheter.A balloon catheter was inflated at the neck of the aneurysm to hold the implanted coils in aneurysm so that the subject coil could be retrieved with the microcatheter.The physician confirmed after procedure that the tip of the microcatheter was deformed.The subject coil was mechanical detached after removal from the patient ¿s body.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The device was returned within the microcatheter.Visual inspection was performed on the returned device and it was observed that the coil was stretched and detached from the delivery wire.; however, it was reported that the coil had been mechanically detached by the user after the event.The delivery wire was kinked.The reported defect was confirmed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based on the investigation results and available information an assignable cause of procedural factors will be assigned to the reported device difficulty engaging target vessel and to the main coil stretched.

• Brand Name: TARGET HELICAL NANO 1.5MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8881247
• Report Number: 3008881809-2019-00237
• Device Sequence Number: 16695946
• Product Code: HCG
• UDI-Device Identifier: 04546540698032
• UDI-Public: 04546540698032
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• 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): 10/10/2019

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: 12/05/2021
• Device Catalogue Number: M0035431520
• Device Lot Number: 21075108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR