MAUDE Adverse Event Report: CODMAN NEURO CODMAN NEURO; SUNDT-KEES AND MCFADDEN ANEURYSM CLIPS

Device Problems Normal (1422); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Intracranial Hemorrhage (1891); Peripheral Vascular Disease (2002)

Event Date 08/12/2016

Event Type  Death  

Event Description

An (b)(6) male admitted with leg weakness and fall, no loss of consciousness or head trauma on (b)(6) 2016.Pt had a recent history of tachy-brady syndrome and was being followed by cardiology with plan for a permanent pacemaker placement.Pt had a ct of his chest/abdomen and pelvis showing widespread metastatic disease.Mri of the thoracic spine was ordered to rule out spine metastasis in the setting of leg weakness.Pt did have a significant past history of peripheral vascular disease with history of abdominal aortic aneurysm repair, with left leg bypass graft in addition to aneurysm surgery in 1982 or 1983 at (b)(6) hospital.However, there was no readily available info regarding clipping of aneurysm.Pt was alert and oriented and had the mri check list presented to him twice, once on the nursing unit and then in the mri suite and pt denied having any metal in his body.During the mri, pt became unresponsive and had a code stroke called, repeat ct head scan showed a large intracranial bleed.Findings discussed with family and decision was made for comfort care and pt expired on (b)(6) 2016.Final autopsy results received on (b)(6) 2016 with cause of death attributed to the rupture of the aneurysm of the right posterior communicating artery.The previously placed aneurysm clips were present: one sundt-kees clip at the point to tri-furcation of the right mca and one mcfadden clip at the a1 segment of the left aca.There was no evidence of vascular tear or damage at or adjacent to the clips, or evidence of displacement of the clips as both clips were present at their original location as referenced on the cranial ct's.

• Brand Name: CODMAN NEURO
• Type of Device: SUNDT-KEES AND MCFADDEN ANEURYSM CLIPS
• Manufacturer (Section D): CODMAN NEURO; raynhamn MA 02767
• MDR Report Key: 5980606
• MDR Text Key: 55750140
• Report Number: 5980606
• Device Sequence Number: 1
• Product Code: HCH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2016
• Distributor Facility Aware Date: 08/12/2016
• Device Age: 18 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 74