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

Model Number	H7493952832220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in a coronary artery.A 2.25x32mm promus premier¿ drug-eluting stent was advanced into the guide catheter; however, it was noted that the stent came off of the balloon and was sticking as it entered the guide catheter.The device was retrieved but it loosen on the balloon catheter and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier us mr 2.25x32mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.Distal end of the stent to the mid-section were damaged with stent struts stretched and pulled distally along the balloon with the distal end of the stent covering the distal balloon cone.The stent has also moved slightly on the balloon in a distal direction.The proximal end of the stent was undamaged.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 hypotube found multiple hypotube kinks.A visual and tactile examination of shaft polymer extrusion revealed multiple kinks on the inner and outer material.Multiple sites of inner shaft polymer extrusion bunching occurred on the distal inner close to the bicomponent bond and stretching which occurred on the port bond for a length of 4mm.A visual and microscopic examination found damage to the tip.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in a coronary artery.A 2.25x32mm promus premier drug-eluting stent was advanced into the guide catheter; however, it was noted that the stent came off of the balloon and was sticking as it entered the guide catheter.The device was retrieved but it loosen on the balloon catheter and the procedure was completed with a different device.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: 7747147
• Report Number: 2134265-2018-06785
• Device Sequence Number: 1258341
• Product Code: NIQ
• UDI-Device Identifier: 08714729844945
• UDI-Public: 08714729844945
• 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): 07/09/2018

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: 08/08/2018
• Device Model Number: H7493952832220
• Device Catalogue Number: 39528-3222
• Device Lot Number: 0020304257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1