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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493892815200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Type  Injury  
Manufacturer Narrative
Tang l, et al. , (2018). Percutaneous management of iatrogenic aortocoronary dissection complicating diagnostic angiography or percutaneous coronary intervention. Arquivos brasileiros de cardiologia, 109(3) p. 259-263. Complainant name: (b)(6) hospital. It is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported via literature that vessel dissection occurred. The patient presented with effort angina for four months. Angiography showed severe stenosis of the distal right coronary artery (rca). Vascular access was obtained via a transradial approach. A non-bsc guidewire and guide catheter were advanced to the target lesion. The distal lesion was predilated using 2. 0×15mm maverick 2 balloon. Immediately after removing the balloon, the patient complained of anterior chest pain and back pain. Angiography revealed a dissection at the rca ostium, extending retrogradely into the sinus of valsalva and ascending aorta. A 2. 5×24 mm non-bsc stent was immediately implanted at the rca ostium to cover the entry point and rca ostium, followed by post-dilatation. After stenting, angiogram demonstrated no further extravasation of contrast medium. An emergent computed tomography angiography (cta) scan showed a limited intramural hematoma of ascending aorta. The clinical course was uneventful. At two-month follow-up, control cta showing total resolution of the intramural hematoma. The trigger for the dissection was thought to be direct trauma caused by the tip of the guiding catheter.
 
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Brand NameMAVERICK²¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7050364
MDR Text Key92717350
Report Number2134265-2017-11862
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493892815200
Device Catalogue Number38928-1520
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 Received11/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/21/2017 Patient Sequence Number: 1
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