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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC IRELAND SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number SPR1520X
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 02/20/2017
Event Type  Death  
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient had 3 resolute integrity drug-eluting stents implanted in the mid lcx with no issues reported during the procedure. The stents were fully expanded. All devices were inspected prior to use with no issues noted. When the operation was near to the end, angiography shown quite a large amount of thrombus on lm to lcx, lad timi i, the patient had chest tightness. The patient was treated with medication and chest tightness released 5 minutes after the treatment, lad timi ii. The physician then attempted to use an export aspiration catheter but no obvious thrombus was removed. The angiography shown the thrombus on opening of lcx disappeared and the timi 0 from middle to distal of lcx. Patient¿s chest tightness worsened, and had sweatiness, nausea and vomiting. Patient was injected with medication and another attempt was made to aspirate the thrombus using the export catheter but still no obvious thrombus removed out. It is reported that the export failed to aspirate. Patient received 300 thousand unit of urokinase at middle of lcx but no improvement. Patient¿s blood pressure decreased, additional medication was administered. The physician used a sprinter 1. 5 x 20 mm balloon catheter in the lcx at 6atm, blood flow did not improve. Iabp was implanted to left femoral artery and trachea cannula supporting breath. Patient lost consciousness, blood pressure was at 60/40 mmhg and heart rate at 50 bpm. Patient was sent to icu and died. Cause of death was acute thrombosis.
 
Manufacturer Narrative
Cine image review; review of procedural images received show a tight distal lm stenosis. Mid-lad has a stent in situ with slow flow through an area of restenosis. The cx origin is affected by the lm distal stenosis as is the lad. Thus a lm 1:1:1 lesion. The cx mid-vessel has a 50% lesion. The rca has a slight aneurysm proximally and the origin of the posterior lv branch has a 70% stenosis. Images show several dilatations in lm to lad with wire in cx. Also lad stent dilatation with improved flow but still timi ii after. After further long stenting in mid-lad the flow is better. The stent in lm to lad gives excellent flow to lad but origin of cx is compromised in diameter but not in flow. Stent place in cx origin with improved appearance and good flow to lad. Visible rapid clot accumulation in cx origin and blocking lad flow. No kissing balloon treatment so not clear if both stents are opened to their respective vessels. This might be why aspiration catheter didn¿t cross. Flow is re-established for a while but not maintained.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSPRINTER RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6428044
MDR Text Key70680568
Report Number9612164-2017-00320
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSPR1520X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/23/2017 Patient Sequence Number: 1
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