MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D-AV; EMBOLIZATION COIL

Model Number 100515HS3D-V-A

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

A review of the approved device history records indicated the lot met all release criteria.Based on the available information, it can be concluded that the coil stretched.No anomalies were identified.Potential cause could be that the coil caught on a previously deployed coil and stretched while positioning.This cannot be determined definitively.

Event Description

It was reported from (b)(6) that during the treatment of an aneurysm, upon coil repositioning, the coil stretched.A snare was used to successfully retrieve the coil.No patient injury was reported.

• Brand Name: HYPERSOFT 3D-AV
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: eva manus ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6100686
• MDR Text Key: 59836319
• Report Number: 2032493-2016-00286
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425025611
• UDI-Public: (01)00811425025611(11)160310(17)210310(10)160310V5
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/10/2021
• Device Model Number: 100515HS3D-V-A
• Device Lot Number: 160310V5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• 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
• Patient Outcome(s): Required Intervention