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

Model Number MC162156S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Rupture (2208)

Event Date 08/22/2018

Event Type  Death  

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 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however, the entire stent could not be recaptured into the microcatheter, so the entire stent/microcatheter system was withdrawn together as a single unit.As the system was being removed, it moved the headway that was positioned in the aneurysm, and the aneurysm ruptured.Protamine was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
• Type of Device: MICROCATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 8011999
• MDR Text Key: 125269271
• Report Number: 2032493-2018-00234
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)180420(17)210331(10)180420115
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: MC162156S
• Device Lot Number: 180420115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 10/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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): Death; Life Threatening
• Patient Age: 40 YR
• Patient Weight: 55