MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO MICROCATHETER

Model Number	MC162156S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	08/22/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use identifies vessel or aneurysm perforation, intracerebral/intracranial hemorrhage, and death as potential complications associated with use of the device.The device was used during the same procedure as was reported in mfr report# 2032493-2018-00233.
Event or Problem Description
It was reported that stent-assisted coiling of a vertebral artery aneurysm was attempted.The headway microcatheter was placed across the aneurysm neck in the basilar artery and an attempt was then made to deploy the lvis stent.The stent opened distally and the distal flared ends apposed well to the vessel wall; however, after more than 40% of the stent had been deployed, it did not open at the neck of the aneurysm.An attempt was made to re-sheath the stent; however, the entire stent could not be recaptured into the microcatheter, so the entire stent/microcatheter system was withdrawn together as a single unit.As the system was being removed, it moved the headway that was positioned in the aneurysm, and the aneurysm ruptured.Protamine was administered immediately and the procedure was aborted.The patient was taken to the icu for observation and after a day, the patient died.Aneurysm rupture was determined to be the cause of the patient's death.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8011999
• Report Number: 2032493-2018-00234
• Device Sequence Number: 1463917
• Product Code: DQO
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)180420(17)210331(10)180420115
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2018

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: MC162156S
• Device Lot Number: 180420115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 40 YR
• Patient Weight: 55