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

Model Number	9589
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(6).
Event or Problem Description
It was reported that stent damage had occurred.A percutaneous coronary intervention was to be performed.During preparation, the physician tried loading the 2.75 x 38mm promus premier drug-eluting stent into the watchdog hemostasis valve and it crushed the stent.This occurred outside of the patient's body.The procedure was completed with another of the same stent and the original watchdog without further issue.
Event or Problem Description
It was reported that stent damage had occurred.A percutaneous coronary intervention was to be performed.During preparation, the physician tried loading the 2.75 x 38mm promus premier drug-eluting stent into the watchdog hemostasis valve and it crushed the stent.This occurred outside of the patient's body.The procedure was completed with another of the same stent and the original watchdog without further issue.
Additional Manufacturer Narrative
Device is a combination product.E1.Initial reporter facility name: (b)(6) hospital.Device returned to manufacturer: an examination of the crimped stent found stent damage.Stent struts from the distal end of the stent were noted to be lifted from their crimped position and pulled proximally.The undamaged crimped stent outer diameter was measured using a snap gauge and the result was 0.0405 inches which is within max crimped stent profile measurement.An examination of the distal tip showed no signs of damage.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 at several locations along the hypotube shaft.The device was returned with hemostasis valve attached to manifold.A visual examination of the outer and inner lumen and mid-shaft section 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: 9649091
• Report Number: 2134265-2020-00621
• Device Sequence Number: 379493
• Product Code: NIQ
• UDI-Device Identifier: 08714729845010
• UDI-Public: 08714729845010
• 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): 02/27/2020

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: 06/07/2020
• Device Model Number: 9589
• Device Catalogue Number: 9589
• Device Lot Number: 0023097336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1