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

Model Number	H7493952816250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 2.50x16mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, when the device was loaded onto the wire, the device broke.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system was returned for analysis.A visual and tactile examination of the midshaft section found the midshaft broken at 4.2cm distal from the hypotube to the midshaft bond.The outer extrusion, inner lumen and bi-component bond showed no signs of damage or strain.A visual and tactile examination found several hypotube kinks across the length of the shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination of the crimped stent found no issues with the crimped stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent outer diameter was measured and reading is within the specification.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.The bumper tip of the device showed no signs of damage.No other issues were identified during product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 2.50x16mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, when the device was loaded onto the wire, the device broke.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: 6255899
• Report Number: 2134265-2016-12594
• Device Sequence Number: 16392207
• Product Code: NIQ
• UDI-Device Identifier: 08714729844716
• UDI-Public: (01)08714729844716(17)20170423(10)18577286
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/20/2016

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: 04/23/2017
• Device Model Number: H7493952816250
• Device Catalogue Number: 39528-1625
• Device Lot Number: 18577286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR