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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ LONG; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ LONG; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911338300
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years and older.Device is a combination product.(b)(4).
 
Event Description
It was reported that a stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 38mm in length target lesion was located in the severely tortuous, severely calcified and 3mm in diameter right coronary artery.A 3.00x38mm promus element¿ long stent was advanced to treat the target lesion.However, the device could not cross the lesion and it was noted that the stent struts were deformed.The device was removed and the procedure was completed with another of the same device.No patient complication were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: stent delivery system was returned for analysis.A visual and microscopic examination of the stent found damage to proximal stent rows 3,6 and 11 with stent struts lifted and pulled distally.The crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The distal tip was visually and microscopically examined and no damage was noted.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 of the device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.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 & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
Event Description
It was reported that a stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 38mm in length target lesion was located in the severely tortuous, severely calcified and 3mm in diameter right coronary artery.A 3.00x38mm promus element¿ long stent was advanced to treat the target lesion.However, the device could not cross the lesion and it was noted that the stent struts were deformed.The device was removed and the procedure was completed with another of the same device.No patient complication were reported and the patient's status was stable.
 
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Brand Name
PROMUS ELEMENT ¿ LONG
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key7652542
MDR Text Key112853049
Report Number2134265-2018-05926
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/10/2019
Device Model NumberH7493911338300
Device Catalogue Number39113-3830
Device Lot Number21521117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2018
Date Manufacturer Received07/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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