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

Model Number	100206HS-V
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
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 has been returned to the manufacturer.The investigation is underway.
Event or Problem Description
It was reported that during the treatment of a left side superficial para-auricular arteriovenous malformation, the coil detached successfully; however, during removal of the pusher, friction was encountered.The pusher wire stretched and then broke in the microcatheter.The entire pusher was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.The patient was reported to be doing well.
Additional Manufacturer Narrative
The pusher was returned for analysis, limiting the scope of the investigation.The distal end of the pusher had been broken off and was not returned for analysis.The pusher was found to be bent in multiple locations throughout the hypotube.It cannot be determined if this damage to the hypotube was present prior to the return shipment for investigation.The transition section of the pusher was found to be broken; however, it cannot be determined if this damage occurred during shipment return or during the procedure.The distal side of the returned portion of the pusher was found to have a stretched body coil.The coil was elongated into a single strand.The coil was broken and the distal end missing.The green lead wire was also found to be broken.Based upon the investigation analysis and available information, the reported complaint was able to be confirmed.The pusher was found to be broken upon return from the field.The pusher was found to be stretched at the distal end of the returned portion of the pusher.No definitive root cause can be determined.The microcatheter and caught portion of the pusher were not returned limiting the scope of the investigation.Historically the observed damage is the result of a pusher/implant that is caught in the microcatheter upon retraction.

• Brand Name: MICROPLEX HYPERSOFT HELICAL VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8484527
• Report Number: 2032493-2019-00078
• Device Sequence Number: 1575861
• Product Code: HCG
• UDI-Device Identifier: 00816777020628
• UDI-Public: (01)00816777020628(11)181003(17)230930(10)1810035PH
• 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): 03/12/2019

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: 09/30/2023
• Device Model Number: 100206HS-V
• Device Lot Number: 1810035PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR