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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493918432300
Device Problem Obstruction of Flow (2423)
Patient Problems Reocclusion (1985); Chest Tightness/Pressure (2463)
Event Date 05/07/2018
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. 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
Promus element china clinical study. It was reported that the patient experienced cardiogenic chest tightness and in-stent restenosis occurred. In (b)(6) 2014, the patient was referred for cardiac catheterization and the index procedure was performed on the same day. The target lesion was located in the proximal left anterior descending (lad) artery extending up to mid lad with 80% stenosis, and was 32mm long with a reference vessel diameter of 3mm. The target lesion was treated with direct placement of 3. 00x32mm promus element¿ plus drug-eluting stent and the residual stenosis was 0%. After five days, the patient was discharged on clopidogrel and other antiplatelets. In (b)(6) 2018, the patient was diagnosed with cardiogenic chest tightness and hospitalized on the same day. Two days after, the 80% in-stent restenosis noted in the mid lad of the previously placed study stent extending up to distal lad was treated with percutaneous coronary intervention (pci) with 0% residual stenosis. After three days, the event was recovered/ resolved and the patient was discharged on the same day.
 
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Brand NamePROMUS ELEMENT¿ PLUS
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 Key7720295
MDR Text Key115060772
Report Number2134265-2018-07135
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P110010
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 07/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/10/2015
Device Model NumberH7493918432300
Device Catalogue Number39184-3230
Device Lot Number16989200
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 Received07/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2014
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: 07/25/2018 Patient Sequence Number: 1
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