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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911320250
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.(b)(4).
 
Event Description
It was reported that shaft break occurred.The 85% stenosed, 20x2.5mm target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 2.50x20mm promus element ¿ drug-eluting stent was advanced to treat the lesion.However, during procedure, it was noted that the delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.:(b)(4), mr, 2.5 x 20mm stent delivery system (sds) was returned.A visual examination of the crimped stent found no issues with the crimped 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.The stent od (outer diameter) of the stent was measured and was within the maximum crimped stent specification indicating that there were no issues with the crimp stent profile.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 a hypotube fracture 188mm distal of the strain relief and multiple hypotube kinks along the full catheter length.The fracture may have occurred due to the application of excessive force which may have initially kinked the device and then resulted in the hypotube fracturing.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that shaft break occurred.The 85% stenosed, 20x2.5mm target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 2.50x20mm promus element ¿ drug-eluting stent was advanced to treat the lesion.However, during procedure, it was noted that the delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
PROMUS ELEMENT ¿
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 Key6186495
MDR Text Key62789387
Report Number2134265-2016-11775
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/06/2017
Device Model NumberH7493911320250
Device Catalogue Number39113-2025
Device Lot Number18934778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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