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

Model Number	H7493952812300
Medical Device Problem Code	Bent (1059)
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
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 3.00x12mm promus premier¿ drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the stent struts were broken.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the proximal end of the stent was damaged with stent struts lifted and pulled distally.The undamaged crimped stent outer diameter (od) was measured and the result was within maximum crimped stent profile measurement.A visual and microscopic examination found damage to the 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 a tear at the guidewire exchange port.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 3.00x12mm promus premier drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the stent struts were broken.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: 6983657
• Report Number: 2134265-2017-10631
• Device Sequence Number: 497273
• Product Code: NIQ
• UDI-Device Identifier: 08714729844679
• UDI-Public: 08714729844679
• 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: 10/02/2018
• Device Model Number: H7493952812300
• Device Catalogue Number: 39528-1230
• Device Lot Number: 20506894
• 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: 11/03/2017
• Initial Report FDA Received Date: 10/27/2017
• 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