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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number SPL20012X
Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)
Patient Problems Myocardial Infarction (1969); Occlusion (1984); ST Segment Elevation (2059); Heart Failure (2206); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Event Date 04/26/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the procedure, an attempt was made to use one sprinter legend rx ptca balloon catheter to treat a moderately tortuous and severely calcified proximal left anterior descending artery lesion exhibiting 99% stenosis. There were no abnormalities in relation to the anatomy. There was no damage noted to packaging. There were no issues noted when removing the device from the hoop/tray. No difficulties noted when removing the protective sheath / packaging stylette from the device. The device was inspected with no issues. Negative prep was performed with no issues identified. The lesion was not pre-dilated. The device did not pass through a previously-deployed stent. The lesion was prepped with rotablation. An attempt was made to advance and inflate the sprinter legend device. Resistance was not noted while advancing the device to the lesion. It was reported that on the first inflation/deflation the balloon was slow to deflate. Contrast was perceived to be in the balloon. The device was not moved or repositioned prior to the deflation difficulties. On the second inflation the balloon would not deflate. It was reported that multiple attempts were made, with the indeflator and an empty syringe, to deflate the balloon without success. The physician was able to advance more contrast into the balloon, but none could be removed. The device was withdrawn from the patient, still inflated, to the guide catheter and the system was removed together. It was reported that the patient had visible st elevations during the period of time that the balloon remained inflated. There was no diagnosis of myocardial infarction made. Coronary angiography post balloon removal revealed dissection of the lad. It was reported that the balloon deflation failure caused the dissection. Another guide was placed and stents were implanted in the proximal lad. Contrast mixture used was 50/50 contrast to hep saline. Patient is alive.
 
Manufacturer Narrative
Additional information: the device returned with a detachment. The detachment occurred as they were attempting to remove the inflated balloon from the patient. The detached portion was removed from the patient. No further intervention was required to remove the detached portion. Evaluation summary: the device returned with a detachment on the distal shaft 111cm distal to the strain relief. The distal shaft material was jagged and stretched at the detachment site. The distal portion of the device was not returned for analysis. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The heavily calcified mid lad, was initially successfully treated with rotational atherectomy. The sprinter legend received two inflations with a maximum inflation pressure of 12 atm. The sprinter balloon was occlusive and had to be removed, and was pulled through the mid lad and back into the guide catheter. Once in the guide catheter, the shaft of the balloon broke, but the balloon still remained inflated. The vessel was able to be rewired and stented with three overlapping des (resolute onyx 2. 25 x 22mm at 14 atm, 3. 0 x 30mm at 16 atm and 2. 25 x 22 at 12 atm. Dissection of the distal lad, was successfully treated with ptca only (too small for stenting). Post procedure the patient had a trans-thoracic echocardiogram which revealed grade 1 diastolic dysfunction with a decreased ejection fraction of 45% and small to moderate pericardial effusion without hemodynamic compromise. Patient developed a fever and elevated cardiac enzymes. Diagnosed with post-percutaneous coronary intervention mi due to dissection of the lad. Physician concluded that the post procedure mi was due to the distal lad dissection, secondary to the inflated balloon complication. Post procedure mi led to development of heart failure. Patient had known case of af on chronic anticoagulation but post pci complications precipitated new af episodes, delayed recovery and prolonged hospitalisation. Patient developed atrial fibrillation which required medication. Patient had systemic inflammatory response syndrome. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional info: the procedure was prompted by evidence of ischaemia and unstable angina. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSPRINTER LEGEND RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7536697
MDR Text Key109001042
Report Number9612164-2018-01205
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/07/2020
Device Model NumberSPL20012X
Device Catalogue NumberSPL20012X
Device Lot Number213982086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2017
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: 05/23/2018 Patient Sequence Number: 1
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