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

Model Number 100203HS-V-A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated that 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 not yet been returned to the manufacturer for evaluation.The investigation is currently ongoing.

Event Description

It was reported that during advancement of the 6th embolization coil, excessive resistance was encountered.During removal, the coil unexpectedly detached in the microcatheter.Both segments of the coil were removed in their entirety.There was no reported intervention or patient injury.The current patient's status is reported to be good.

Manufacturer Narrative

The device was returned for evaluation; however, the microcatheter and were not received.The monofilament was exposed by cutting the black pet and stretching the coils.The striations noted on the monofilament are indicative of tensile stretch.Based on the investigation and provided information, the complaint of a detached implant could be confirmed.The root cause is unknown, although the device exhibits evidence that it was subjected to tensile forces that exceeded the strength specifications of the monofilament.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780
• MDR Report Key: 6620871
• MDR Text Key: 76965624
• Report Number: 2032493-2017-00132
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425025246
• UDI-Public: (01)00811425025246(11)161219(17)211130(10)161219V2
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

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: Physician
• Device Expiration Date: 11/30/2021
• Device Model Number: 100203HS-V-A
• Device Lot Number: 161219V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 05/08/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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