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

Model Number	H7493952812270
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. the investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the moderately tortuous and non-calcified obtuse marginal branch.After a guide catheter was placed, a 2.75x12mm promus premier¿ drug-eluting stent was advanced for treatment.However, it was noted under fluoroscopy that the device was unable to advance and the stent was dislodged inside the guide catheter.The dislodged stent was removed together with the guide catheter and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
(b)(6).(b)(4).Device evaluated by mfr.: promus premier us mr 2.75 x 12mm stent delivery system was returned for analysis.The stent was stretched.The distal end of the stent was moved over the distal markerband.The proximal end of the stent was moved over the proximal markerband.The stent was observed to be crimped on the balloon.The manufacturing data for this device was reviewed and no anomalies were highlighted with the crimp details.The maximum stent profile for this device was within max crimped stent profile measurement.The balloon cones were reviewed and there were no issues noted.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the hypotube revealed a break at 766 mm distal to the distal end of the strain relief.There were multiple kinks along the hypotube.There were multiple inner/outer shaft polymer extrusion kinks noted.The tip was visually examined and damage was noted.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 investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
It was further reported that the catheter was noted to be broken inside the guide catheter after the device was attempted to inflate.The device was completely removed.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7482951
• Report Number: 2134265-2018-03977
• Device Sequence Number: 159624
• Product Code: NIQ
• UDI-Device Identifier: 08714729844662
• UDI-Public: 08714729844662
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• 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): 04/10/2018

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: 05/13/2018
• Device Model Number: H7493952812270
• Device Catalogue Number: 39528-1227
• Device Lot Number: 20009457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR