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

Model Number	H7493925232300
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Promus premier us, otw, 3.0x32 mm, stent delivery system was returned for analysis.A visual examination of the crimped stent found stent strut, row 5, from the distal end was lifted and bent back in a distal direction.The stent od (outer diameter) of the undamaged section was measured and was within the maximum crimped stent specification indicating that there were no issues with the crimp stent profile.A visual examination of the balloon cones was performed 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 found no issue with the hypotube shaft.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found no damage to the tip.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
Reportable based on analysis completed on 14-aug-2017.It was reported that crossing difficulties were encountered.  the target lesion was located in the right coronary artery(rca).A 32 x 3.00 promus element stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.However, returned device analysis revealed stent damage.It was further reported that the stent damage occurred during removal of the device from the patient's body.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6827302
• Report Number: 2134265-2017-08614
• Device Sequence Number: 1228019
• Product Code: NIQ
• UDI-Device Identifier: 08714729829126
• UDI-Public: (01)08714729829126(17)20180215(10)0019654870
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 08/14/2017

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: 02/15/2018
• Device Model Number: H7493925232300
• Device Catalogue Number: 39252-3230
• Device Lot Number: 0019654870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1