MAUDE Adverse Event Report: AESCULAP AG AVM MICROCLIP PHYNOX CVD.2MM STERILE; CEREBRO VASCULAR CLIPS

Model Number FE962K

Device Problem Failure to Seal (4070)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product fe962k - avm microclip phynox cvd.2mm sterile.According to the complaint description, the avm clips stayed open after being loaded and prepared on the applier.Four (4) clips were initially attempted.The patient was required to return to the operating room (or) after the interventional radiology (ir) procedure.Then, three (3) more clips were tried later that same day.A revision was required.Additional information was not provided, but has been requested.The adverse event is filed under aag reference: (b)(4).Associated medwatch-reports: 9610612-2023-00279 ((b)(4) + fe964k), 9610612-2023-00280 ((b)(4) + fe964k), 9610612-2023-00281 ((b)(4) + fe963k), 9610612-2023-00282 ((b)(4) + fe963k), 9610612-2023-00284 ((b)(4) + fe963k), 9610612-2023-00285 ((b)(4) + fe953k).Involved component: fe908k / phynox avm clip app fcps tub shaft90mm - lot 2380 ((b)(4)).

Event Description

Update: after the devices were received, leading and involved components were confirmed.The phynox avm clip applier is now considered to be the leading material, (aesculap ag reference no.(b)(4)), and all clips are involved components.Associated medwatch report: 9610612-2024-00051 (aesculap ag reference no.(b)(4) + fe908k).Involved components: 9610612-2023-00279 (aesculap ag reference no.(b)(4) + fe964k).9610612-2023-00280 (aesculap ag reference no.(b)(4) + fe964k).9610612-2023-00281 (aesculap ag reference no.(b)(4) + fe963k).9610612-2023-00282 (aesculap ag reference no.(b)(4) + fe963k).9610612-2023-00283 (aesculap ag reference no.(b)(4) + fe962k).9610612-2023-00284 (aesculap ag reference no.(b)(4) + fe963k).9610612-2023-00285 (aesculap ag reference no.(b)(4) + fe953k).

Event Description

Additional information was received: the procedure was an open craniotomy for avm resection.Implantation of aneurysm clips instead of avm clips was performed.There was an additional estimated one (1) hour of anesthesia time and the need for additional dissection of scar tissue to identify the appropriate location since a clip could not be used as a radiographic marker.The current status of the patient was noted as "doing well".Associated medwatch-reports: 9610612-2023-00279 (aesculap ag reference no.(b)(4) + fe964k).9610612-2023-00280 (aesculap ag reference no.(b)(4) + fe964k).9610612-2023-00281 (aesculap ag reference no.(b)(4) + fe963k).9610612-2023-00282 (aesculap ag reference no.(b)(4) + fe963k).9610612-2023-00283 (aesculap ag reference no.(b)(4) + fe962k).9610612-2023-00284 (aesculap ag reference no.(b)(4) + fe963k).9610612-2023-00285 (aesculap ag reference no.(b)(4) + fe953k).Involved component: fe908k / phynox avm clip app fcps tub shaft90mm - lot 2380 (aesculap ag reference no.(b)(4)).

Manufacturer Narrative

Additional information: b5 - description updated.Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

• Brand Name: AVM MICROCLIP PHYNOX CVD.2MM STERILE
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18425571
• MDR Text Key: 331859491
• Report Number: 9610612-2023-00283
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FE962K
• Device Catalogue Number: FE962K
• Device Lot Number: 52740920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2022
• 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
• Treatment: FE908K - LOT 2380; FE908K - LOT 2380; FE953K - LOT 52789442; FE962K - LOT 52740920; FE963K - LOT 52651966; FE963K - LOT 52820281; FE963K - LOT 52820281; FE964K - LOT 52678351; FE964K- LOT 52735049
• Patient Outcome(s): Required Intervention