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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493925120400
Device Problems Stent; Inadequacy of Device Shape and/or Size
Event Type  Injury  
Manufacturer Narrative

Device is a combination product. (b)(4). Device evaluated by mfr. : the device was not returned for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).

 
Event Description

It was reported that vessel perforation occurred. The 75% stenosed target lesion was located in the severely tortuous and severely calcified left main artery to proximal left anterior descending (lad) artery. A 20 x 4. 00 promus premier¿ drug eluting stent was advanced to treat the lesion. When the stent was placed, a vessel perforation occurred. After insertion of an intra-aortic balloon pump (iabp), hemostasis was performed with a balloon and at the same time, a pericardial puncture was performed. Subsequently, a ¿cover stent¿ was then deployed and the procedure was completed. The next day, the iabp was removed. Eight days post procedure, the patient was discharged. The patient's status was stable. It was noted intravenous ultrasound (ivus) had not been performed prior to stent placement, and choosing an oversized stent had been suspected as the cause of the event.

 
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Brand NamePROMUS PREMIER¿
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6746455
Report Number2134265-2017-07471
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH7493925120400
Device Catalogue Number39251-2040
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 Received07/07/2017
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: 07/27/2017 Patient Sequence Number: 1
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