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

Model Number	H7493952828350
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 3.50x28mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, upon unpacking, the middle part of the stent appeared buckled.The device was never used inside the patient.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg promus premier us mr 3.50x28mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Proximal and central struts were damaged; struts were lifted, stretched and pulled in distal direction.The undamaged distal section of the crimped stent od (outer diameter) 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 tactile examination of the hypotube found multiple kinks along its length.A visual and tactile examination of the shaft polymer extrusion revealed a mid-shaft kink on the proximal side of the port exchange site.A visual and microscopic examination of the tip revealed no issues.No other issues were identified during 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 stent damage occurred.A 3.50x28mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, upon unpacking, the middle part of the stent appeared buckled.The device was never used inside the patient.The procedure was completed with another of the same device.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: 7059771
• Report Number: 2134265-2017-11623
• Device Sequence Number: 16619766
• Product Code: NIQ
• UDI-Device Identifier: 08714729844921
• UDI-Public: 08714729844921
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 10/14/2017
• Device Model Number: H7493952828350
• Device Catalogue Number: 39528-2835
• Device Lot Number: 0019198700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1