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

Model Number	H7493952832220
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 2.25x32mm promus premier drug-eluting stent was selected for use to treat the lesion.However, during preparation, it was noticed that some of the stent struts looked bent on the stent delivery system (sds).The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: promus premier us mr 2.25 x 32mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent identified damage.Strut segment 7 from the proximal end of the stent was lifted and pulled in a distal direction.The remainder of the stent was undamaged.The crimped stent od (outer diameter) was measured and was 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 device found multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues were noted.The product stent protector was not returned for analysis with the device, however the specified inside diameter of the stent protector was reviewed.Based on the specified stent protector profile and the crimped stent outer diameter for this device, there were no issues to note with the interaction between the two components, provided that the product stent protector was removed correctly.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.A 2.25x32mm promus premier¿ drug-eluting stent was selected for use to treat the lesion.However, during preparation, it was noticed that some of the stent struts looked bent on the stent delivery system (sds).The procedure was completed with another of the same 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: 6868222
• Report Number: 2134265-2017-09527
• Device Sequence Number: 16350592
• Product Code: NIQ
• UDI-Device Identifier: 08714729844945
• UDI-Public: (01)08714729844945(17)20180808(10)0020304257
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/08/2017

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: 08/08/2018
• Device Model Number: H7493952832220
• Device Catalogue Number: 39528-3222
• Device Lot Number: 0020304257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1