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

Model Number	H7493952828250
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.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 dislodgement occurred.The target lesion was located in the distal right coronary artery (rca).After a non-bsc device caused a proximal dissection in the rca, a 3.0mm x12mm and a 2.5mm x 28mm promus premiers stent was successfully implanted in the rca to cover a dissection.Subsequently, another 2.50x28mm promus premier¿ drug-eluting stent was advanced and was attempted to be deployed distally to the previous stents.However, the device failed to cross the two previously implanted stents.Upon retrieving, the stent got dislodged and had to be crushed into the rca wall where the two stents were implanted.The distal portion of the spiral dissection was not covered.No further patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6149447
• Report Number: 2134265-2016-11098
• Device Sequence Number: 877130
• Product Code: NIQ
• UDI-Device Identifier: 08714729844891
• UDI-Public: (01)08714729844891(17)20170917(10)19080216
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2017
• Device Model Number: H7493952828250
• Device Catalogue Number: 39528-2825
• Device Lot Number: 19080216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2016
• Initial Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5MM X 28MM PROMUS PREMIER; 3.0MM X12MM PROMUS PREMIER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR