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

Model Number	H7493952820300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.A 3.00x20mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, during unpacking, it was noted that the shaft halfway between hub and distal tip was broken.The device was never used inside the patient and the procedure was completed with another stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier us, mr 3.0x20mm, stent delivery system was returned for analysis.A visual and tactile examination of the device found a hypotube break at 908mm from distal end of strain relief.There were also multiple hypotube kinks along the catheter length noted.A visual examination of the crimped stent found stent strut rows 2, 3 and 7 (counting from distal end of stent) lifted from stent profile.The undamaged stent od (outer diameter) was measured and was within specification indicating that there were no issues with the crimp stent profile.A visual examination of the balloon showed that 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 found multiple shaft polymer extrusion kinks and damage to the exchange port site.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found no damage to the tip.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.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.A 3.00x20mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, during unpacking, it was noted that the shaft halfway between hub and distal tip was broken.The device was never used inside the patient and the procedure was completed with another stent.No patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6990987
• Report Number: 2134265-2017-10738
• Device Sequence Number: 10873705
• Product Code: NIQ
• UDI-Device Identifier: 08714729844792
• UDI-Public: 08714729844792
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/13/2017

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: 01/28/2019
• Device Model Number: H7493952820300
• Device Catalogue Number: 39528-2030
• Device Lot Number: 20984526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1