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

Model Number	H7493952838300
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
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 a coronary artery.A 3.00x38mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the stent was frayed and the device failed to cross the lesion.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: promus premier us mr 3.00 x 38mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found distal stent damage.Struts 1and 2 from the distal end of the stent were lifted and pulled distally.Struts 2-10 from the distal end of the stent were slightly damaged.The crimped stent od (outer diameter) of the undamaged section was measured and was within max crimped stent profile measurement.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 catheter length.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and slight damage was 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 most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.A 3.00x38mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, the stent was frayed and the device failed to cross the lesion.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: 6459856
• Report Number: 2134265-2017-03353
• Device Sequence Number: 18973625
• Product Code: NIQ
• UDI-Device Identifier: 08714729845027
• UDI-Public: (01)08714729845027(17)20180703(10)20131188
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: 07/03/2018
• Device Model Number: H7493952838300
• Device Catalogue Number: 39528-3830
• Device Lot Number: 20131188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1