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

Model Number	H7493952838400
Medical Device Problem Code	Bent (1059)
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; 2134265-2018-01264.It was reported that stent damage 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
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: promus premier us mr 4.00 x 38mm stent delivery system was returned for analysis.The crimped stent was examined and no issues were noted.The stent showed no signs of damage or movement and was set equidistant between the proximal and distal markerbands.The outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed 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 a break at approximately 592mm distal from the distal end of the strain relief.There were multiple hypotube kinks noted.The shaft polymer extrusion was examined and there were no issues noted.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 manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
Same case as mdr id; 2134265-2018-01264.It was reported that stent damage 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: 7286217
• Report Number: 2134265-2018-01265
• Device Sequence Number: 1110047
• Product Code: NIQ
• UDI-Device Identifier: 08714729845041
• UDI-Public: 08714729845041
• 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: 03/12/2019
• Device Model Number: H7493952838400
• Device Catalogue Number: 39528-3840
• Device Lot Number: 0021152296
• 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: 03/13/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1