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 Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.A 2.75 x 24 mm promus premier was advanced into a watchdog hemostasis valve and resistance was felt which destroyed the distal end of the stent.The stent did not enter the patient's body.The watchdog was removed and the procedure was completed with another of the same stent device.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.A 2.75 x 24 mm promus premier was advanced into a watchdog hemostasis valve and resistance was felt which destroyed the distal end of the stent.The stent did not enter the patient's body.The watchdog was removed and the procedure was completed with another of the same stent device.No patient complications were reported in relation to this event.Device evaluated by manufacturer: promus premier, us, mr 2.75 x 24 mm stent delivery system was returned for analysis.A visual examination of the stent found that the distal stent struts were pushed pulled distally and stretched over the tip.The undamaged proximal stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred when the stent interacted with the hemostasis valve.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, hypotube, outer and inner lumen as well as the mid-shaft section found no issues.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: 8029015
• Report Number: 2134265-2018-62522
• Device Sequence Number: 11137732
• Product Code: NIQ
• UDI-Device Identifier: 08714729844846
• UDI-Public: 08714729844846
• 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): 12/04/2018

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: 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: 10/31/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1