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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 H7493918428400
Device Problems Kinked (1339); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. Device is a combination product. (b)(4). Device evaluated by mfr: a promus element plus ous, mr 4. 0x28mm, stent delivery system (sds) was returned for analysis. A visual examination of the crimped stent found proximal struts 1 & 2 were lifted. It is likely the crimped stent may have encountered resistance & subsequent damage during the attempt to withdraw the device. The undamaged stent outer diameter (od) was measured and is within the maximum crimped stent specification, indicating that there were no issues with the crimp stent profile. A visual examination of the balloon showed that the balloon cones were reviewed and no issues were noted. A visual and tactile examination found no issue with the shaft polymer extrusion. The bi-component bond showed no signs of damage or strain. A visual and tactile examination of the device found a hypotube break at approximately 260mm distal to the distal end of the strain relief. There were also multiple severe hypotube kinks along the full catheter length. The kinks may have occurred due to the application of excessive force. A visual and tactile examination found no damage to the tip. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. 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
Reportable based on analysis completed on 11-dec-2017. It was reported that advancing difficulties and shaft kink were encountered. The target lesion was located in the tortuous anatomy left main left anterior descending (lad) artery. After a 6f femoral guiding catheter was engaged, a 4. 00x28mm promus element¿ plus drug-eluting stent was advanced to treat the lesion. However, while advancing, the device was stuck in the guiding catheter and when the physician pushed the device further, the shaft was kinked. The stent delivery system was then retrieved and the procedure was completed with a non-bsc stent. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed proximal stent damage and hypotube break. It was further reported that the shaft kinked was noticed upon retrieval of the stent delivery system and it was intact when removed from the patient.
 
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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 Key7151842
MDR Text Key96023460
Report Number2134265-2017-12681
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,distri
Reporter Occupation
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/24/2017
Device Model NumberH7493918428400
Device Catalogue Number39184-2840
Device Lot Number19446182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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