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

Model Number	H7493952828270
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
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 2.75x28mm promus premier¿ drug-eluting stent was selected for use to treat the lesion.However, it was noted that the stent struts were damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier us mr 2.75 x 28mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal marker bands.The crimped stent outer diameter (od) was measured which is within max 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 no issues.An examination of the shaft polymer extrusion revealed a break at the port bond site.The tip was visually examined and no issues were noted.A stent protector was returned with the device and the inner diameter (id) of the stent protector was measured which is within measurement.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 2.75x28mm promus premier¿ drug-eluting stent was selected for use to treat the lesion.However, it was noted that the stent struts were damaged.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6757541
• Report Number: 2134265-2017-07856
• Device Sequence Number: 13763782
• Product Code: NIQ
• UDI-Device Identifier: 08714729844907
• UDI-Public: (01)08714729844907(17)20170917(10)19084952
• Combination Product (Y/N): N
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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: 09/17/2017
• Device Model Number: H7493952828270
• Device Catalogue Number: 39528-2827
• Device Lot Number: 19084952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1