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

Model Number	H7493952838300
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-03358.It was reported that catheter entrapment occurred.A 2.50x16mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, during preparation, the stent came out of its hoop with the edge of the stent struts deformed.The device was not used inside the patient.A 3.00x38mm promus premier¿ drug-eluting stent was then advanced to treat the lesion.However, during the procedure the device became stuck with the non-bsc guide extension catheter.The procedure was completed using a different device.There were no patient complications nor harm 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 on the 5 most distal stent rows, stent struts were damaged and lifted from their crimp positions, the remainder of stent appeared undamaged.A review of the manufacturing data for the stent profile was performed.The maximum crimped stent profile was measured which is within the stent profile specification.The tip was visually and microscopically examined and it was noted that the tip was damaged at the distal edge of the tip.This type of damage is consistent with excessive force being applied to the delivery system.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 kinks on the several locations along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the inner and outer lumen and mid-shaft polymer extrusion profile found no issues with the extrusion shaft.The bicomponent bond showed no signs of damage or strain.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 most probable cause of the reported difficulties may be due interaction with another device.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-03358.It was reported that catheter entrapment occurred.A 2.50x16mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, during preparation, the stent came out of its hoop with the edge of the stent struts deformed.The device was not used inside the patient.A 3.00x38mm promus premier¿ drug-eluting stent was then advanced to treat the lesion.However, during the procedure the device became stuck with the non-bsc guide extension catheter.The procedure was completed using a different device.There were no patient complications nor harm reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6499611
• Report Number: 2134265-2017-03359
• Device Sequence Number: 16340710
• Product Code: NIQ
• UDI-Device Identifier: 08714729845027
• UDI-Public: (01)08714729845027(17)20180508(10)19967459
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/22/2017

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: 05/08/2018
• Device Model Number: H7493952838300
• Device Catalogue Number: 39528-3830
• Device Lot Number: 19967459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1