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

Model Number	H7493952838300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.After a guide was placed in the lesion, a 3.00x38mm promus premier¿ drug-eluting stent was attempted to be advanced but the shaft of the stent broke at about midway up.The break occurred outside the patient's body so the device was able to be removed without problem.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
device evaluated by mfr.: promus premier ous, mr 3.0x28mm stent delivery system was returned for analysis.A visual and tactile examination of the device found a hypotube break at 725mm from distal end of strain relief.There were also multiple hypotube kinks along the catheter length noted.The break may have occurred due to the application of excessive force which may have initially kinked the device and then resulted in the hypotube breaking.A visual examination of the crimped stent found proximal stent damage, stent struts flattened and misaligned on the proximal end.The undamaged stent outer diameter was measured and was within the maximum crimped stent 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 no issue with the shaft polymer extrusion.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 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.The target lesion was located in a coronary artery.After a guide was placed in the lesion, a 3.00x38mm promus premier¿ drug-eluting stent was attempted to be advanced but the shaft of the stent broke at about midway up.The break occurred outside the patient's body so the device was able to be removed without problem.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6944241
• Report Number: 2134265-2017-10137
• Device Sequence Number: 891632
• Product Code: NIQ
• UDI-Device Identifier: 08714729845027
• UDI-Public: 08714729845027
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/27/2017

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: 08/30/2018
• Device Model Number: H7493952838300
• Device Catalogue Number: 39528-3830
• Device Lot Number: 0020379403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1