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

Model Number	9589
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00x38mm promus premier drug-eluting stent was advanced for treatment.However, while loading the delivery system onto a non-bsc guidewire, the stent came off the balloon.The stent delivery system was pulled out off the wire and the procedure was completed with a 3.00x32mm synergy drug-eluting stent.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: promus premier,us, mr 3.00 x 38 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from proximal to mid stent region were noted to be lifted from their crimped position and pulled in a distal and proximal orientation.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.An examination (visual and via scope) found no issues with the tip.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00x38mm promus premier drug-eluting stent was advanced for treatment.However, while loading the delivery system onto a non-bsc guidewire, the stent came off the balloon.The stent delivery system was pulled out off the wire and the procedure was completed with a 3.00x32mm synergy drug-eluting stent.No patient complications nor injuries 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: 10036566
• Report Number: 2134265-2020-05337
• Device Sequence Number: 16890492
• Product Code: NIQ
• UDI-Device Identifier: 08714729845027
• UDI-Public: 08714729845027
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/24/2020

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: 04/27/2021
• Device Model Number: 9589
• Device Catalogue Number: 9589
• Device Lot Number: 0024743906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1