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

Model Number	9586
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Date of event: used (b)(6) 2019 as event date since the correct date was not provided.
Event or Problem Description
It was reported that stent damage occurred.A 2.75x24mm promus premier drug-eluting stent was selected for use.The stent was crimped when it was taken out of sterile packaging/ hoop.However, it was noted that the stent architecture was compromised.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.A 2.75x24mm promus premier drug-eluting stent was selected for use.The stent was crimped when it was taken out of sterile packaging/ hoop.However, it was noted that the stent architecture was compromised.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.B3 - used (b)(6) 2019 as event date since the correct date was not provided.Device evaluated by mfr.: promus premier us mr 2.75 x 24 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.The stent showed no signs of movement and was set between the proximal and distal markerbands.An undamaged section of the crimped stent outer diameter was measured and the result was within maximum 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 microscopic examination of the bumper tip found no issues.A visual and tactile examination of the hypotube identified multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer lumen 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.

• 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: 8689842
• Report Number: 2134265-2019-06779
• Device Sequence Number: 14046479
• Product Code: NIQ
• UDI-Device Identifier: 08714729844846
• UDI-Public: 08714729844846
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 10/23/2019
• Device Model Number: 9586
• Device Catalogue Number: 9586
• Device Lot Number: 0022077907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1