MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME FRAMING COIL; EMBOLIZATION COIL

Model Number 100408HFRM-V

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Infarction, Cerebral (1771); Occlusion (1984); Thrombosis (2100)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided; therefore, a review of the approved device history records could not be performed.The coil remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies parent artery occlusion, ischemia, vasospasm, coil migration or misplacement, clot formation, and neurological deficits including stroke, as potential complications associated with use of the device.Three coils were implanted in the aneurysm.It is unknown which coil was associated with the loop that extended into the parent vessel; therefore, medwatch reports will be submitted for all coils.The second coil is captured in mfr report# 2032493-2018-00231.The third coil is captured in mfr report# 2032493-2018-00232.

Event Description

It was reported that coil embolization was performed on (b)(6) 2018 to treat a ruptured basilar apex aneurysm.Approximately two weeks later on (b)(6) 2018, the patient presented with left-sided weakness and a diagnostic angiogram was performed for vasospasm.The angiogram confirmed coil loop prolapse into the right p1 segment of the pca, with associated sub-total occlusive thrombus along the extent of the coil.A heparin infusion drip was administered, followed by oral aspirin and plavix.An mri brain scan on (b)(6) 2018 demonstrated multiple areas of restricted diffusion in the occipital region and right thalamus, and small infarctions, likely embolic, were noted.Follow-up mri on (b)(6) 2018 showed resolving areas of restricted diffusion and no new areas of infarction.The patient's weakness has ultimately improved, but has not completely resolved.

• Brand Name: HYDROFRAME FRAMING COIL
• Type of Device: EMBOLIZATION COIL
• 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: 8011920
• MDR Text Key: 125270341
• Report Number: 2032493-2018-00230
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 100408HFRM-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 94