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

Model Number	H7493952828300
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/19/2017
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.During unpacking of a 3.00x28mm promus premier¿ drug-eluting stent, it was noted that the mid section of the stent struts were bent.The device never entered the patient's body and the procedure was completed with a new stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: stent delivery system (sds) was returned for analysis.A visual examination of the stent found that stent struts on the proximal stent rows 5-6 were flared and deformed.The undamaged section of the crimped stent od (outer diameter) was measured and was within the maximum crimped stent profile measurement.Stent damage most likely occurred due to handling of the device during unpacking.A visual examination of the bumper tip showed no signs of damage.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 kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive pressure being applied on the delivery system.A visual and tactile examination of the inner and outer lumen and mid-shaft section found no issues with the shaft polymer extrusion.The bicomponent bond showed no signs of damage or strain.No other issues were identified during the product analysis.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.During unpacking of a 3.00x28mm promus premier¿ drug-eluting stent, it was noted that the mid section of the stent struts were bent.The device never entered the patient's body and the procedure was completed with a new 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: 6922308
• Report Number: 2134265-2017-09847
• Device Sequence Number: 873589
• Product Code: NIQ
• UDI-Device Identifier: 08714729844914
• UDI-Public: 08714729844914
• 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): 09/19/2017

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: 07/08/2018
• Device Model Number: H7493952828300
• Device Catalogue Number: 39528-2830
• Device Lot Number: 20165283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1