MAUDE Adverse Event Report: AESCULAP AG YASARGIL PERM STD-CLIP SLT-CVD 8.3MM; CEREBRO VASCULAR CLIPS

Model Number FE752K

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2021

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 fe752k - yasargil perm std-clip slt-cvd 8.3mm.According to the complaint description, the closing forces for clip was weak.The case was recurrent aneurysm and he gave the clipping surgery again.He supposes that the recurrent aneurysm is come from the weak closing force from phynox clips which the patient was implanted ever.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00094 ((b)(4) + fe752k), 9610612-2021-00095 ((b)(4) + fe711k), 9610612-2021-00096 ((b)(4)+ fe711k).

Manufacturer Narrative

Investigation results: visual investigation: here we found three different clip sizes instead of two.Thus, the reported reference code may not be correct.Also the batch numbers could not be determined using the combination "article number with serial number".A check by the production department was requested.The visual inspection revealed only slight signs of use, but no visible deviation or damage.Furthermore the products were send to the quality assurance of the production department for further analysis.Due to the analysis reports of the production department: material:fe752k; specification: closing force; reference: 1.77n ±0.177n; current state: closing force actual: 2,03n; the closing force is too high.Cause: the closing force has increased minimally.The clip otherwise complies with the target specifications.It cannot be explained that this minimally too high closing force should have caused the recurrent aneurysm.No fault could be detected on the production side.Material: fe752k; specification: closing force; reference: 1.77n ±0.177n; current state: closing force; actual: 1,55n; the closing force is minimally too low.Cause: the closing force is minimally too low.The clip condition is generally ok.Material: fe692k; specification: closing force; reference: 1,08n ±0,108n; current state: closing force; actual: 1,22n; the closing force is minimally too high.Cause: the closing force has increased minimally.The clip otherwise complies with the target specifications.It cannot be explained that this minimally too high closing force should have caused the recurrent aneurysm.No fault could be detected on the production side.Material: fe682k; specification: closing force; reference: 1,08n ±0,108n; current state: closing force; actual: 1,15n; cause: the closing force corresponds to the specifications no fault could be detected on the production side.Batch history review: batch history review is not yet available.In our regular sap system the device quality and manufacturing history records are not available for such old manufacturing dates regarding this manufacturing date.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

The adverse event is filed under aag reference (b)(4) ((b)(4)).Associated medwatch-reports: 9610612-2021-00094 ((b)(4)+ fe752k); 9610612-2021-00095 ((b)(4)+ fe682k); 9610612-2021-00096 ((b)(4)+ fe711k); 9610612-2021-00093 ((b)(4)+ fe692k).

• Brand Name: YASARGIL PERM STD-CLIP SLT-CVD 8.3MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11338021
• MDR Text Key: 232192922
• Report Number: 9610612-2021-00093
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• PMA/PMN Number: K833650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FE752K
• Device Catalogue Number: FE752K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention