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

Model Number	H7493952816350
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 stent damage occurred.A 3.50x16mm promus premier¿ drug-eluting stent was advanced for treatment.However, it was noted that the stent was defective when it was advanced over the guide wire and failed to cross the lesion.The procedure was completed with a different stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier us, mr, 3.5x16mm, stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent identified damage to the first 5 most proximal struts.The first two struts were lifted and pulled distally.The undamaged crimped stent outer diameter (od) was measured and was within the maximum crimped stent specification indicating that there were no issues with the crimp stent profile.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 hypotube kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issue with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.The device was loaded on a 0.014'' guide wire and no resistance was felt.A visual and tactile examination found slight damage to the tip.The type of damage evident is consistent with resistance being encountered during advancement.No other issues were identified during the product analysis.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 3.50x16mm promus premier¿ drug-eluting stent was advanced for treatment.However, it was noted that the stent was defective when it was advanced over the guide wire and failed to cross the lesion.The procedure was completed with a different stent.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: 6988998
• Report Number: 2134265-2017-10629
• Device Sequence Number: 18857288
• Product Code: NIQ
• UDI-Device Identifier: 08714729844747
• UDI-Public: 08714729844747
• 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: Nurse
• 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: 09/10/2018
• Device Model Number: H7493952816350
• Device Catalogue Number: 39528-1635
• Device Lot Number: 20433062
• 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: 11/02/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1