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

Model Number	H7493952824400
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.During preparation, a 4.00x24mm promus premier¿ drug-eluting stent was advanced over 014 thruway guide wire to treat the lesion.However, the stent delivery system (sds) became stuck on the wire.When the physician attempted to remove the sds from the guidewire, the stent catheter broke.The guidewire and the sds were removed together.The procedure was completed with another thruway guidewire and another promus premier¿ stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: 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 distal edge of the bumper tip of the device showed signs of damage.This type of damage is consistent with excessive force being applied to the delivery system.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found a break in the port exchange site.The outer extrusion section of the port site was stretched for 3.3cm before breaking.Inner extrusion damage 2mm distal of bi-component weld was also noted.There was evidence of medium inside the inner/outer lumen.The distal section of the delivery system was detached and returned loaded on guidewire.As part of the analysis, the 0.014'' guidewire was removed from the distal end of the device with no restriction noted.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 catheter entrapment and shaft break occurred.During preparation, a 4.00x24mm promus premier¿ drug-eluting stent was advanced over 014 thruway guide wire to treat the lesion.However, the stent delivery system (sds) became stuck on the wire.When the physician attempted to remove the sds from the guidewire, the stent catheter broke.The guidewire and the sds were removed together.The procedure was completed with another thruway guidewire and another promus premier¿ stent.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: 6190923
• Report Number: 2134265-2016-11778
• Device Sequence Number: 893272
• Product Code: NIQ
• UDI-Device Identifier: 08714729844877
• UDI-Public: (01)08714729844877(17)20171018(10)19197446
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/02/2016

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: 10/18/2017
• Device Model Number: H7493952824400
• Device Catalogue Number: 39528-2440
• Device Lot Number: 19197446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• 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