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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 H7493918408250
Device Problems Shaft; Hole In Material
Event Date 04/10/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is combination product. (b)(4). Device evaluated by mfr: the stent delivery system was returned for analysis. A visual examination of the stent found no issues on the stent. There were no signs of damage, stretching or lifting of the stent struts. The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands. A visual examination of the bumper tip showed no signs of damage. The balloon cones were reviewed and no issues were noted. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. A visual and tactile examination found severe hypotube kinks along several locations of the hypotube shaft. This type of damage most likely occurred due to application of excessive force on the delivery system. A visual and tactile examination of the inner and outer lumen and mid-shaft section found a kink in shaft polymer extrusion at 37 mm distal to wire exchange port and the core-wire was kinked at this site also. Another kink in mid-shaft extrusion at 39mm proximal to wire exchange port was also noted. The type of damages noted most likely occurred due to application of excessive force on the delivery system. The bicomponent bond showed no signs of damage or strain. Red substance (appeared to be blood) was also observed inside the balloon and outer extrusion lumen during device examination. As part of analysis, the device was loaded onto a recommended 0. 014'' guidewire without issues. Leak test was performed by attempting to inflate the balloon to 18 atmospheres using an inflation device. The balloon did not inflate due to a shaft leak that was noted. A tear on the outer shaft polymer extrusion (longitudinal tear 2 mm in length) was observed at 74 mm distal to the wire exchange port (the tear was located 1258mm distal to the distal end of the strain relief). 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

The target lesion was located in the distal rca. It was reported that there was a hole in the shaft of the promus element¿ plus, therefore the balloon could not be inflated for positioning of the stent. There were no patient complications related to this event and the procedure was completed with another of the same device.

 
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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 Key7496291
Report Number2134265-2018-03678
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/24/2019
Device MODEL NumberH7493918408250
Device Catalogue Number39184-0825
Device LOT Number20930813
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/14/2017
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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