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

Model Number	H7493952832220
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.During preparation of a 2.25x32mm promus premier¿ stent, it was noted that the stent came off on the back table after the stent protective cover was removed.The device was replaced and 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.A visual examination of the crimped stent found the stent separated from the sds.The stent was damage; stretched across its entire length.The maximum crimped stent profile was measured and was within specification.A review of the batch records for the stent crimp force and the crimp temperature for the device all meet the specification.A visual examination found that the balloon wings appeared relaxed with dried medium present inside the balloon.A visual and tactile examination found multiple hypotube kinks along the catheter length.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.A visual examination found no tip damage.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 handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.During preparation of a 2.25x32mm promus premier stent, it was noted that the stent came off on the back table after the stent protective cover was removed.The device was replaced and 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: 7421464
• Report Number: 2134265-2018-02867
• Device Sequence Number: 39291
• Product Code: NIQ
• UDI-Device Identifier: 08714729844945
• UDI-Public: 08714729844945
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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: 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: 03/27/2018
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1