MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING

Model Number	H7493952812300
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The patient presented with st-segment elevation myocardial infarction.The target lesion was located in a coronary artery.A 3.00x12mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, when the device was advanced through the guiding catheter, it was unable to advance into the coronary system and was removed.When the physician re-advanced the device, it was noted that a strut was sticking up.The procedure was completed with a different stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: promus premier us mr 3.00 x 12mm stent delivery system was returned for analysis.The crimped stent was examined and damage was noted.Distal struts 1-2 were stretched and lifted in a proximal direction.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was measured and was within max crimped stent profile measurement.The balloon cones were reviewed and there were no issues to note.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the hypotube revealed multiple kinks.An examination of the shaft polymer extrusion revealed no issues.The tip was visually examined and damage was noted.No other issues were identified during the product analysis.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 or Problem Description
It was reported that stent damage occurred.The patient presented with st-segment elevation myocardial infarction.The target lesion was located in a coronary artery.A 3.00x12mm promus premier drug-eluting stent was advanced to treat the lesion.However, when the device was advanced through the guiding catheter, it was unable to advance into the coronary system and was removed.When the physician re-advanced the device, it was noted that a strut was sticking up.The procedure was completed with a different stent.No patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7396184
• Report Number: 2134265-2018-02845
• Device Sequence Number: 1608299
• Product Code: NIQ
• UDI-Device Identifier: 08714729844679
• UDI-Public: 08714729844679
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2018
• Device Model Number: H7493952812300
• Device Catalogue Number: 39528-1230
• Device Lot Number: 0020658825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1