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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 10/21/2016
Event Type  Death  
Manufacturer Narrative
Literature reference: dx. Doi. Org/10. 1016/j. Wneu. 2016. 1064. 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
From journal article: the safety and efficacy of non-compliant balloon angioplasty was reported for treatment of subarachnoid haemorrhage-induced cerebral vasospasm at three major academic institutions in the united states. Vessels treated include the internal carotid artery (ica), middle cerebral artery (mca), anterior cerebral artery (aca), basilar artery (ba), posterior cerebral artery (pca), posterior inferior cerebellar artery (pica) and vertebral artery (va). Aneurysmal subarachnoid haemorrhage (sah) was present in 50 patients, whereas the sah was from an unknown source in 2 patients. The sprinter legend balloon was the most commonly used balloon during the angioplasty procedures. During the procedure, the balloon was inflated to nominal pressure at a rate of 2-4 atm per minute using a manual insufflation device and repositioned after deflation as needed. All procedures used non-compliant balloons. The mca and intracranial ica were the most commonly treated vessels. No procedure related complications were reported. There was improvement in angiographic vasospasm in 97% of cases without any associated procedural morbidity or mortality. Outcome included delayed cerebral ischemia. Functional outcome after discharge from icu included patient death.
 
Manufacturer Narrative
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.
 
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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 Key7343421
MDR Text Key102569194
Report Number9612164-2018-00518
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
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/08/2018
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: 03/15/2018 Patient Sequence Number: 1
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