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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 H7493918420220
Device Problem Detachment of Device or Device Component (2907)
Patient Problems High Blood Pressure/ Hypertension (1908); Device Embedded In Tissue or Plaque (3165)
Event Date 10/27/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that removal difficulty and balloon detachment occurred and that the patient had hypertension.The 80% stenosed, 2.25mm in diameter target lesion was located in the non-tortuous, non-calcified small side vessel from the left anterior descending artery (lad).As the 2.25x20mm promus element plus stent delivery system was advanced to treat the lesion.The stent was deployed at 12 bar for 10 seconds and then the balloon was deflated.During withdrawal, a small resistance was recognized and a piece of the balloon tore off.The balloon piece remained inside the patient and no retrieval attempt was made.The patient experienced femoral discomfort and high blood pressure but stabilized following treatment with medicine.The procedure was not completed due to this event.
 
Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.The stent was not returned for analysis.It was deployed inside the patient¿s body as per complaint report.The polymer extrusion shaft consisting of the balloon and the tip were not returned for analysis.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system of the device.A visual and tactile examination of the outer and mid-shaft section found that there was an inner/outer extrusion shaft break at 3 mm distal of the port exchange site; the core-wire was noted to be exposed.The port exchange bond was ripped open on the top side and the mid-shaft was twisted and stretched distal of the hypotube/mid-shaft bond site.A review of the manufacturing data was performed to verify that the shaft of device was not broken prior to shipping.The types of damages noted are consistent with excessive force being applied to the delivery system of the device.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
Event Description
It was reported that removal difficulty and balloon detachment occurred and that the patient had hypertension.The 80% stenosed, 2.25mm in diameter target lesion was located in the non-tortuous, non-calcified small side vessel from the left anterior descending artery (lad).As the 2.25x20mm promus element plus stent delivery system was advanced to treat the lesion.The stent was deployed at 12 bar for 10 seconds and then the balloon was deflated.During withdrawal, a small resistance was recognized and a piece of the balloon tore off.The balloon piece remained inside the patient and no retrieval attempt was made.The patient experienced femoral discomfort and high blood pressure but stabilized following treatment with medicine.The procedure was not completed due to this event.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the shaft break occurred after the procedure when loading the device into the hoop for return.
 
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Brand Name
PROMUS ELEMENT¿ PLUS
Type of Device
STENT, 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 Key7028044
MDR Text Key91936983
Report Number2134265-2017-11163
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2019
Device Model NumberH7493918420220
Device Catalogue Number39184-2022
Device Lot Number20829444
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age88 YR
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