CARDIOMEMS ENDOSURE SENSOR S2-2080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-09-19 for CARDIOMEMS ENDOSURE SENSOR S2-2080 manufactured by Cardiomems, Inc..

Event Text Entries

[917485] This case occurred 2008. The sensor was placed without difficultly into the aorta prior to main body insertion. The sensor was then lowered into the common iliac above the iliac aneurysm. The main body of the stent graft was deployed. Ballooning took place and then attempts were made to lower the sensor into the aneurysm sac past the main body of the stent graft. There was difficultly in doing this but after multiple attempts the sensor was successfully lowered into the aneurysm sac. There was a pressure drop in the patient so the contralateral limb was placed and the pressure was then stabilized. The case ended successfully with the sensor in the excluded iliac aneurysm. At no time during the case was there discussion of the iliac aneurysm rupturing. The cardiomems endosure pressure measurement system is not indicated for use in iliac aneurysms. On september 09, 2008, the physician spoke with cardiomems personnel and stated the iliac aneurysm had ruptured on the day of sensor implantation and that he thought that this was related to the force required to maneuver the sensor delivery catheter into the iliac aneurysm. He requested that we report this incident. At no time during the case was there discussion of the iliac aneurysm rupturing and no additional action was taken in regard to care of the patient. September 09, 2008 was the first time that cardiomems was received this information.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004936110-2008-00007
• MDR Report Key: 1164103
• Report Source: 07
• Date Received: 2008-09-19
• Date of Report: 2008-09-12
• Date of Event: 2008-07-17
• Date Added to Maude: 2008-09-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MRS. GRACE POWERS
• Manufacturer Street: 387 TECHNOLOGY CIRCLE NW SUITE 500
• Manufacturer City: ATLANTA GA 30313
• Manufacturer Country: US
• Manufacturer Postal: 30313
• Manufacturer Phone: 6786512300
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARDIOMEMS ENDOSURE SENSOR
• Generic Name: IMPLANTABLE INTRA-ANEURYSM PRESSURE MEASUREMENT SYSTEM
• Product Code: NQH
• Date Received: 2008-09-19
• Catalog Number: S2-2080
• Operator: PHYSICIAN
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: Y
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 1187698
• Manufacturer: CARDIOMEMS, INC.
• Manufacturer Address: 387 TECHNOLOGY CIRCLE NW SUITE 500 ATLANTA GA 30313 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-09-19