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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 Problems Thrombus (2101); Patient Problem/Medical Problem (2688)
Event Date 07/08/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Journal name: vascular disease management title of article: inadvertent percutaneous coronary endarterectomy: an unreported complication of percutaneous coronary intervention issue: 2017;14 (1): e11-e15 note: date of event has been populated with date literature article was received prior to acceptance. 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
A pre-catheterization profile was performed and a radial approach with a 5 fr tiger non-medtronic catheter. The left coronary system showed no significant lesions, but mehran type iii in-stent restenosis (isr) was noted in the ostio proximal rca stent. Pci was performed using a mdt guide catheter (6f judkins 3. 5) and a sprinter legend balloon (2 x 10mm). Post dilatation showed a longitudinal homogenous opacity moving from the proximal rca and embedded into the distal rca, causing timi 0 flow. An attempt to disintegrate the thrombus via balloon manipulation failed. Thrombosuction was successfully performed and flow restored across the rca. The ostio proximal rca was stented using a non-mdt stent. It was reported that most likely aggressive manipulation of the 6f fr judkins right catheter must have triggered the ostial rca dissection, leading to its total occlusion. Patient was discharged after 48 hours.
 
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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 Key6663158
MDR Text Key101004333
Report Number9612164-2017-00807
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2017
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 Received05/26/2017
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: 06/23/2017 Patient Sequence Number: 1
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