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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number UNK854
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Perforation of Vessels (2135); Cardiogenic Shock (2262)
Event Date 11/28/2017
Event Type  Death  
Manufacturer Narrative
Device evaluated by mfr: 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
Same case as mfr report#: 2134265-2017-12990. It was reported that stent damage and vessel perforation occurred and the patient expired. The 90% stenosed, 3. 0mm in diameter target lesion was located in the highly calcified right coronary artery (rca). The target lesion was treated with pre-dilation and placement of a 3. 0x32mm synergy ii drug eluting stent. Following post-dilation with a 3. 0mm nc emerge balloon catheter, a perforation was noticed, which was covered with a non-bsc stent. The rca was recovered. Upon further investigation, it was noticed that there was a stent fracture, which was most likely caused by the balloon inflations. The stent remained in one piece but it appeared that the struts were pushed out of alignment. Another 70% stenosed target lesion was located in the heavily calcified and moderately sized left anterior descending artery (lad). The patient was coded in the lab and the lad was opened with plain old balloon angioplasty. Hours later the patient expired. The cause of death was probably cardiogenic shock. No autopsy was performed.
 
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Brand NameNC EMERGE®
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 Key7137930
MDR Text Key95487790
Report Number2134265-2017-12991
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK854
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 Received11/30/2017
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 Initial

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
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