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

Model Number	H7493952828350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-01265.It was reported that shaft break occurred.A 3.50x28mm promus premier¿ stent was selected for use.However, upon loading the device over the wire, the stent broke in half.The device was replaced with a 4.00x38mm promus premier¿ stent but the stent was damaged upon trying to insert the device into the sheath.No patient complications were reported.
Additional Manufacturer Narrative
Updated: device evaluated by mfr.Device evaluated by mfr: the promus premier us mr 3.50 x 28mm stent delivery system was returned for analysis.The crimped stent was examined and damage was noted to the mid-section.Struts 7-19 from the proximal end of the stent were lifted and damaged.The remainder of the stent was undamaged.The undamaged proximal stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were examined and there were no issues noted.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the hypotube revealed multiple kinks.The shaft polymer extrusion was examined and no issues were noted.The bi-component bond showed no signs of damage or strain.The tip was visually examined and damage was noted.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-01265.It was reported that shaft break occurred.A 3.50x28mm promus premier stent was selected for use.However, upon loading the device over the wire, the stent broke in half.The device was replaced with a 4.00x38mm promus premier stent but the stent was damaged upon trying to insert the device into the sheath.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: 7286213
• Report Number: 2134265-2018-01264
• Device Sequence Number: 19161759
• Product Code: NIQ
• UDI-Device Identifier: 08714729844921
• UDI-Public: 08714729844921
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 03/26/2019
• Device Model Number: H7493952828350
• Device Catalogue Number: 39528-2835
• Device Lot Number: 21234875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1