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

Model Number	H7493952824350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a coronary artery.A 3.50x24mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stripped off by the non-bsc guide extension catheter.Subsequently, the stent and guide extension catheter were removed together.A synergy stent was then advanced, but failed to cross the lesion.The procedure was completed using a non-bsc stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent had detached from the delivery system and was returned loaded inside the guide catheter.During analysis, the stent was removed from the guide catheter severe damage was noted particularly on the distal stent struts.Dried medium resembling dried blood was also observed on stent struts.Stent damage most likely occurred when the stent got caught at the distal edge of the guide catheter prior to stent placement.The tip was visually and microscopically examined and no damages were noted.The balloon cones were reviewed and no issues were noted.Crimp markings were evident on the entire length of the balloon wall which is evident that the stent was crimped on the balloon prior to stent detachment.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 on the several locations 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 inner and outer lumen and mid-shaft polymer extrusion profile found no issues with the extrusion shaft.The bicomponent 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 cause of the reported difficulties may be due interaction with another device.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a coronary artery.A 3.50 x 24 mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stripped off by the non-bsc guide extension catheter.Subsequently, the stent and guide extension catheter were removed together.A synergy stent was then advanced, but failed to cross the lesion.The procedure was completed using a non-bsc 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: 6493084
• Report Number: 2134265-2017-03564
• Device Sequence Number: 1627494
• Product Code: NIQ
• UDI-Device Identifier: 08714729844860
• UDI-Public: (01)08714729844860(17)20180329(10)19811623
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/27/2017

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: 03/29/2018
• Device Model Number: H7493952824350
• Device Catalogue Number: 39528-2435
• Device Lot Number: 19811623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE EXTENSION CATHETER: GUIDELINER
• Patient Age: 81 YR