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

Model Number	H7493952838300
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that a foreign matter was found.The target lesion was located in a coronary artery.A 3.00x38mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.After several attempts, it was noted that there was a chuck of plastic obstructing the hub.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues on the 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 od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The bumper tip profile of the device showed no signs of damage.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 found no issues with the hypotube profile.The manifold hub of the device was visually examined and no issues were noted with external section of manifold hub and the threads showed no signs of damage.The internal surface of the leur section of the manifold hub appeared to be crushed with a rough edge in one section.The manifold hub was attached to a hand held encore inflation device with no issue noted with the threading.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion profile.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that a foreign matter was found.The target lesion was located in a coronary artery.A 3.00x38mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.After several attempts, it was noted that there was a chuck of plastic obstructing the hub.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: 6377190
• Report Number: 2134265-2017-01913
• Device Sequence Number: 16375051
• Product Code: NIQ
• UDI-Device Identifier: 08714729845027
• UDI-Public: (01)08714729845027(17)20180508(10)19967459
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2017

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: 05/08/2018
• Device Model Number: H7493952838300
• Device Catalogue Number: 39528-3830
• Device Lot Number: 19967459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1