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

Model Number	H7493952820400
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2017
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 4.00x20mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.The device was removed; however, it was noted that a stent strut was bent.The procedure was completed with another 4.00x20mm promus premier¿ drug-eluting stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system was returned for analysis.A visual examination of the stent found that on the first distal row, stent struts were lifted and pulled distally.The undamaged proximal section of the crimped stent outer diameter was measured and is within maximum crimped stent profile measurement.The tip was visually and microscopically examined and signs of damage were noted on the distal edges of the tip.This type of damages is consistent with excessive force being applied to the delivery system.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 kinks along several locations of the hypotube shaft.This type of damages is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the device found an extrusion kink 90mm distal of port weld.This type of damages is consistent with excessive force being applied to the delivery system.The bi-component bond showed no signs of damage or strain.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 4.00x20mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.The device was removed; however, it was noted that a stent strut was bent.The procedure was completed with another 4.00x20mm promus premier¿ drug-eluting stent.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6540052
• Report Number: 2134265-2017-04285
• Device Sequence Number: 16167322
• Product Code: NIQ
• UDI-Device Identifier: 08714729844815
• UDI-Public: (01)08714729844815(17)20180208(10)19627635
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/14/2017

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: 02/08/2018
• Device Model Number: H7493952820400
• Device Catalogue Number: 39528-2040
• Device Lot Number: 19627635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1