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

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.

• Brand Name: SPRINTER RX
• Type of Device: CATHETERS, 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 Key: 6428044
• MDR Text Key: 70680568
• Report Number: 9612164-2017-00320
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SPR1520X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided; 05/30/2017
• Supplement Dates FDA Received: 06/28/2017; 10/02/2017
• 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): Death; Required Intervention
• Patient Age: 47 YR