MAUDE Adverse Event Report: ST. JUDE MEDICAL SYSTEMS AB PRESSUREWIRE AERIS; GUIDEWIRE SENSOR

Model Number C12058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombus (2101); Stenosis (2263); Vascular Dissection (3160)

Event Date 01/27/2014

Event Type  Injury  

Event Description

The patient underwent a percutaneous coronary revascularization with drug eluting stents due to nstemi in (b)(6) 2014.When compared to angiography from (b)(6) 2013, recent angiography showed more stenosis in the right posterior descending artery.The ramus, lad and lcx were unchanged so no ffr was performed.Via the right radial artery, one des stent (promus) was placed in the right posterior descending with good angiographic results.During the procedure, a small thrombus was visible in the proximal right coronary artery confirmed by pct.It was thought to be a restricted dissection induced by the pressurewire aeris during procedure and a des stent (stentys) was placed with good results confirmed by oct.

Manufacturer Narrative

The product was not returned.Since there was no device identification available, a review of the device history record was not possible.We not believe the cause of the dissections was due to a device malfunction or any deficiency with the instructions for use requiring corrective action.We will continue to closely monitor the performance of this product for any significant trends.

• Brand Name: PRESSUREWIRE AERIS
• Type of Device: GUIDEWIRE SENSOR
• Manufacturer (Section D): ST. JUDE MEDICAL SYSTEMS AB; palmbladsgatan 10; box-6350; uppsala SE-75 1 35; SW SE-751 35
• Manufacturer Contact: emil anderas ; palmbladsgatan 10; box 6350; uppsala SE-75-1 35 ; SW SE-751 35 ; 8161000
• MDR Report Key: 3677283
• MDR Text Key: 4256183
• Report Number: 8030904-2014-00005
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C12058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR