ENDOSURE WIRELESS AAA PRESSURE MANAGMENT SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-28 for ENDOSURE WIRELESS AAA PRESSURE MANAGMENT SYSTEM * manufactured by Cardiomems, Inc..

Event Text Entries

[20620735] Patient had aaa repair. Aaa repaired with stent graft and cardiomem sensor placed by surgeon in aneurysm sac. It was noted at the end of the surgical procedure that a countable item was missing. An anterior and posterior x-ray taken of the abdomen. There were not any countable items in the abdominal cavity on x-ray. Patient had a post-op follow-up visit with the surgeon approximately a month later. Another abdominal film was taken. This film revealed a long object (~12 cm) resting next to the aneurysm area. Surgeon and radiologist reviewed the film, and they were unable to determine the identity of the object. The surgeon decided at this time to leave the retained object because it did not seem to be creating any problems for the patient. Patient returned to ed 26 days later with a ruptured aaa. Family made decision in the ed to not treat surgically. Patient was admitted to palliative care. Patient expired two days later. Autopsy performed and revealed retained device to be the tip of the cardiomem delivery catheter. Delivery catheter tip was sent for examination. Preliminary autopsy results revealed that a sharp bone spur on the patient's spine ruptured the posterior wall of the aneurysm, and the retained device was not the causative agent creating the aaa rupture. After autopsy results were returned to surgeon, he remembered that the first cardiomem delivery catheter was slightly bent and had to be exchanged during the procedure. It is believed that during the exchange, the catheter tip from the first cardiomem was unknowingly retained. The second cardiomem catheter was inserted without difficulty. Specific device information unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1003917
MDR Report Key1003917
Date Received2008-01-28
Date of Report2007-09-06
Date of Event2007-06-06
Report Date2007-09-06
Date Reported to FDA2008-01-28
Date Added to Maude2008-02-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameENDOSURE WIRELESS AAA PRESSURE MANAGMENT SYSTEM
Generic NameSENSOR, PRESSURE, WIRELESS, AAA
Product CodeNQH
Date Received2008-01-28
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age1 DY
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key924439
ManufacturerCARDIOMEMS, INC.
Manufacturer Address387 TECHNOLOGY CIRCLE NW SUITE 500 ATLANTA GA 30313 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-01-28

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