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 Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
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 target lesion was located in the heavily calcified right coronary artery (rca).A 3.00 x 12 mm promus premier¿ stent was advanced but failed to cross the lesion.The device was removed and it was noted that the proximal part of the stent got flared.The procedure was completed with a new 3.0 x 12 promus premier stent.No patient complications were reported and patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: promus premier us mr 3.00 x 12mm stent delivery system (sds) was returned for analysis.The crimped stent was examined and proximal stent damage was noted.Proximal strut segments 1 and 2 were damaged and slightly lifted.The remainder of the stent was undamaged.The outer diameter for the undamaged section was measured within max crimped stent profile measurement.The balloon appeared to have been subjected to positive pressure and a vacuum pulled.There was hardened medium resembling blood present in the balloon.A visual and tactile examination of the hypotube revealed multiple kinks.An examination of the shaft polymer extrusion revealed no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues were 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 target lesion was located in the heavily calcified right coronary artery (rca).A 3.00x12mm promus premier stent was advanced but failed to cross the lesion.The device was removed and it was noted that the proximal part of the stent got flared.The procedure was completed with a new 3.0 x 12 promus premier stent.No patient complications were reported and patient's status was good.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6977438
• Report Number: 2134265-2017-10675
• Device Sequence Number: 900008
• Product Code: NIQ
• UDI-Device Identifier: 08714729844679
• UDI-Public: 08714729844679
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/10/2017

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: 20658825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR