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

Model Number 100308HS-V-N

Device Problems Detachment Of Device Component (1104); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

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 has not yet been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that during placement of the 4th embolization coil, resistance was encountered.During removal, the coil unexpectedly detached.Both segments of the coil were removed from the patient.There was no reported intervention or patient injury.The current patient's status is reported to be stable.

Manufacturer Narrative

The pusher and introducer were returned for analysis.The body coil was noted to be stretched, starting from platinum coil.The implant was stretched, with the monofilament broken at the tie knot portion.No damage was noted on the remainder of the pusher, and appeared to be in conformance; however, the second half of the implant was not returned for analysis.Based upon the investigation findings and available information, the complaint of a broken coil was confirmed.The root cause could not be determined; however, the device exhibited evidence that it was subjected to forces that exceeded its strength specification, evident by the stretched coil and broken monofilament.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• 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: 7009498
• MDR Text Key: 92539123
• Report Number: 2032493-2017-00280
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170019500
• UDI-Public: (01)00810170019500(11)170705(17)220630(10)1707051N6
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K132952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

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
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 100308HS-V-N
• Device Lot Number: 1707051N6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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