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

Model Number	9585
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.After deploying a 4.00x20mm promus premier drug-eluting stent, the physician attempted to remove the delivery system; however, the shaft broke approximately 100cm from the hub.The distal end of the delivery shaft was still inside the guide catheter and the rest of the device was outside the patient's body.The physician was then able to remove the guide catheter from the patient's body and retrieved the broken piece.The procedure was completed with no complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: promus premier, us, mr 4.00 x 20 mm stent delivery system was returned for analysis.The stent was not returned for analysis as it was implanted successfully.The balloon cones were reviewed, and they were in a relaxed state.It is evident that the balloon was subjected to pressure.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found a break 120cm distal to the distal end of the strain relief, leaving the core wire exposed.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.After deploying a 4.00x20mm promus premier drug-eluting stent, the physician attempted to remove the delivery system; however, the shaft broke approximately 100cm from the hub.The distal end of the delivery shaft was still inside the guide catheter and the rest of the device was outside the patient's body.The physician was then able to remove the guide catheter from the patient's body and retrieved the broken piece.The procedure was completed with no complications were reported.

• Brand Name: PROMUS PREMIER
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8524703
• Report Number: 2134265-2019-03951
• Device Sequence Number: 2869204
• Product Code: NIQ
• UDI-Device Identifier: 08714729844815
• UDI-Public: 08714729844815
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 07/07/2019
• Device Model Number: 9585
• Device Catalogue Number: 9585
• Device Lot Number: 0021591845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1