MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICALVTA; EMBOLIZATION COIL

Model Number	100204HS-V
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during coil embolization of an aneurysm, the coil stretched and detached during repositioning.The implant was removed in its entirety along with the microcatheter.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
Correction: (e1).A microcatheter was returned for evaluation, but the actual device was not included in the return package.The microcatheter did not have any notable damage.Based on the investigation, the complaint is unverifiable because the actual device was not returned for evaluation.

• Brand Name: MICROPLEX HYPERSOFT HELICALVTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9325402
• Report Number: 2032493-2019-00263
• Device Sequence Number: 13555750
• Product Code: HCG
• UDI-Device Identifier: 00816777020604
• UDI-Public: (01)00816777020604(11)181220(17)231130(10)1812205WH
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2023
• Device Model Number: 100204HS-V
• Device Lot Number: 1812205WH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR