MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICALVTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100306HS-V-A2
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	07/14/2021
Type of Reportable Event	Malfunction
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.The device was returned to the manufacturer for evaluation.The investigation is currently ongoing.
Event or Problem Description
It was reported that an embolization coil implant kept coming out of the aneurysm neck during placement.The coil was removed from the patient where it was observed that the coil was the incorrect size.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
Summary of device evaluation: the investigation of the returned coil found the implant damaged at proximal.And measured to be the correct (hypersoft helical 100306hs-v) implant coil size, that matches the returned pouch label and complaint file.The implant loops and coil length were measured in spec.No damage was found on the returned pusher and introducer sheath.The damage found on the implant can result in a distorted implant shape (i.E.Larger loop diameter).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.The investigation of the returned device did not any other anomaly that would have caused or contributed to the reported complaint.

• Brand Name: MICROPLEX HYPERSOFT HELICALVTA
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 12340476
• Report Number: 2032493-2021-00334
• Device Sequence Number: 11746940
• Product Code: HCG
• UDI-Device Identifier: 00816777024114
• UDI-Public: (01)00816777024114(11)200601(17)250531(10)2006015PH
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091641
• 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): 07/22/2021

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: 05/31/2025
• Device Model Number: 100306HS-V-A2
• Device Lot Number: 2006015PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 89