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

Model Number	9587
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Used (b)(6) 2018 as event date as no event date is provided.Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 3.50x28mm promus premier drug-eluting stent was selected for use to treat a lesion.However, as the device was attempted to be inserted into the patient, the shaft broke.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.50x28mm promus premier drug-eluting stent was selected for use to treat a lesion.However, as the device was attempted to be inserted into the patient, the shaft broke.No patient complications were reported.It was further reported that the procedure was completed with another 3.5x28mm promus and the patient's status was fine.
Additional Manufacturer Narrative
Used (b)(6) 2018 as event date as no event date is provided.Device is a combination product.
Additional Manufacturer Narrative
Describe event or problem, initial reporter title, initial reporter frist name and initial reporter last name updated.Used (b)(6) 2018 as event date as no event date is provided.Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 3.50x28mm promus premier drug-eluting stent was selected for use to treat a lesion.However, as the device was attempted to be inserted into the patient, the shaft broke.No patient complications were reported.It was further reported that the procedure was completed with another 3.5x28mm promus and the patient's status was fine.Device evaluated by mfr: a promus premier,us, mr 3.50x28mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with 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 between the proximal and distal marker bands.The crimped stent outer diameter (od) was measured and is within max crimped stent profile measurement.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 kinks along the full length of the catheter and a hypotube break 705mm distal to the strain relief measured using a ruler.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip found no damage.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.

• 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: 7802435
• Report Number: 2134265-2018-60279
• Device Sequence Number: 1862148
• Product Code: NIQ
• UDI-Device Identifier: 08714729844921
• UDI-Public: 08714729844921
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/15/2018

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: 07/01/2019
• Device Model Number: 9587
• Device Catalogue Number: 9587
• Device Lot Number: 0021579588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 09/20/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/12/2018; 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1