MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 FRAMING COIL VTA; VASCULAR EMBOLIZATION DEVICE

Model Number	100619HFRM-V-A2
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.An investigation of the returned coil system was performed and the pusher and implant were observed to be broken.The proximal end of the implant and distal end of the broken pusher were stuck inside of the microcatheter, which was observed under x-ray.The implant was found severely stretched and still attached to the pusher.The conditions or circumstances that led to the damage could not be determined, but the damage is consistent with the device experiencing forces over specification.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
During treatment of a cavernous fistula coiling procedure, multiple coils were delivered successfully in the facial vein-ophthalmic vein into the cavernous segment.The 6x19 coil was advanced through the microcatheter into the arterial segment.Resistance was reported during advancement of the coil until the coil stopped advancing in the microcatheter.Upon removal from the microcatheter hub, the coil unraveled.The coil was removed by cutting the hub from the microcatheter and tracking a snare parallel to the catheter to remove the system within the guide catheter from the patient successfully.
Additional Manufacturer Narrative
(b3) - replace date on the initial report with actual date (b)(6) 2020.(b4) - replace date on the initial report with actual date 02/10/2021.(h6) - remove medical device problem code 2907 (detachment of device or device component) from initial report.(h6) - add medical device problem code 1664 (unraveled material) to initial report.(h6) - remove investigation findings code 3252 (fracture problem) from initial report.(h6) - remove health effect - impact code 4621 (recognized device or procedural complication) from initial report.(h6) - remove investigaton conclusion code 22 (known inherent risk of device) from initial report.(h10) - remove statement: "the instructions for use (ifu) identifies premature coil.Detachment as a potential complication associated with use of the device.".

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11311002
• Report Number: 2032493-2021-00033
• Device Sequence Number: 1284480
• Product Code: KRD
• UDI-Device Identifier: 00816777023551
• UDI-Public: (01)00816777023551(11)200424(17)250331(10)2004241WF
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 100619HFRM-V-A2
• Device Catalogue Number: 100619HFRM-V
• Device Lot Number: 2004241WF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR