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

Model Number	H7493952838270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the promus premier us mr 2.75 x 38 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found that a stent struts on distal rows 1-4 were pulled and stretched distally to cover part of the distal marker-band.The undamaged section crimped stent maximum outer diameter (od) was measured and is within the maximum crimped stent profile measurement.The tip was visually and microscopically examined and no signs of damage were noted.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 found no kinks or damage along the hypotube shaft.A visual and tactile examination of the inner and outer lumen and mid-shaft found a mid-shaft kink at 55 mm distal from the hypotube/mid-shaft bond.This type of damage is consistent with excessive force being applied on the delivery system.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 investigation conclusion was unable to be determined.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 20-jul-2018.A 2.75x38mm promus premier¿ stent was received with no reported issues.However, returned device analysis revealed distal stent damage.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7755332
• Report Number: 2134265-2018-07189
• Device Sequence Number: 16458443
• Product Code: NIQ
• UDI-Device Identifier: 08714729845010
• UDI-Public: 08714729845010
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 07/20/2018

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: 02/05/2019
• Device Model Number: H7493952838270
• Device Catalogue Number: 39528-3827
• Device Lot Number: 21024046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1