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

Model Number	H7493952820220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent fracture occurred.A 2.25x20mm promus premier¿ drug-eluting stent was selected to treat the lesion.However, it was noticed that a stent strut was broken.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system was returned for analysis.A visual examination of the stent found that there was damage to the proximal end and mid-section of the stent.The proximal end of the stent was pushed in a distal direction with some stent struts misaligned and over lapping in places.Device analysis suggests that all stent struts were intact and no fracture had occurred.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.A visual and microscopic examination found no damage to the distal tip.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 device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the device found that there were no issues with the mid shaft, inner or outer polymer extrusion.No other issues were identified during the product analysis.The investigation conclusion was unable to be determined.(b)(4).
Event or Problem Description
It was reported that stent fracture occurred.A 2.25x20mm promus premier¿ drug-eluting stent was selected to treat the lesion.However, it was noticed that a stent strut was broken.The procedure was completed with a different 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: 6977513
• Report Number: 2134265-2017-10630
• Device Sequence Number: 1156239
• Product Code: NIQ
• UDI-Device Identifier: 08714729844761
• UDI-Public: 08714729844761
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/11/2017

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: 08/21/2018
• Device Model Number: H7493952820220
• Device Catalogue Number: 39528-2022
• Device Lot Number: 0020351318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 10/25/2017
• 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