InjuryHCH

AVM MICROCLIP PHYNOX CVD.4MM STERILE

Received Jan 2, 2024 · Event occurred Dec 11, 2023

Report 9610612-2023-00279 · MDR key 18425554

Device

Generic name

Cerebro Vascular Clips

Manufacturer

Aesculap Ag

Model number

FE964K

Catalog number

FE964K

Lot number

52735049

Product problems

Failure to Seal
Failure to Seal

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

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).

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT FE964K - AVM MICROCLIP PHYNOX CVD.4MM 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 (400634273 + FE964K); 9610612-2023-00280 (400634274 + FE964K); 9610612-2023-00281 (400634275 + FE963K); 9610612-2023-00282 (400634276 + FE963K); 9610612-2023-00283 (400634277 + FE962K); 9610612-2023-00284 (400634278 + FE963K); 9610612-2023-00285 (400634279 + FE953K). INVOLVED COMPONENT: FE908K / PHYNOX AVM CLIP APP FCPS TUB SHAFT90MM - LOT 2380 (B)(4).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

UPDATE: AFTER RECEIPT OF THE DEVICES, 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).