MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D ADVANCED; VASCULAR EMBOLIZATION DEVICE

Model Number	MV-01503HTDA
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The analysis is currently underway.
Event or Problem Description
It was reported that during treatment of an aneurysm, an embolization coil implant appeared shorter in length than expected when advanced through a microcatheter.The coil was then withdrawn and removed from the patient and another coil was used to continue the procedure.Which was completed successfully.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The reported complaint is unconfirmed.The investigation of the returned coil system found the implant stretched at proximal and the pusher's black pet damaged at transition.The device was tested with a compatible lab provided microcatheter and the implant successfully advanced out of the distal end of the catheter without issue and the implant was measured to be within spec.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11980379
• Report Number: 2032493-2021-00224
• Device Sequence Number: 3237305
• Product Code: KRD
• UDI-Device Identifier: 00816777026477
• UDI-Public: (01)00816777026477(11)181001(17)230930(10)1810015P6
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2021

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: MV-01503HTDA
• Device Catalogue Number: 100154HFRM-V
• Device Lot Number: 1906265XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1