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

Model Number	H7493925224400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2016
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 via (b)(4) that stent dislodgement occurred.In (b)(6) 2016, left heart catheterization was performed.The target lesion was located in the radial artery.A 24x4.00mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent came off the balloon resulting in stent embolization in the radial artery.The physician was unable to remove the dislodged stent.The patient and the family was made aware of the incident.Blood flow test was done and no patient complications were noted.The following day, the patient was discharged.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6176787
• Report Number: 2134265-2016-11670
• Device Sequence Number: 413855
• Product Code: NIQ
• UDI-Device Identifier: 08714729829027
• UDI-Public: (01)08714729829027(17)20170507(10)18635725
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2016

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: 05/07/2017
• Device Model Number: H7493925224400
• Device Catalogue Number: 39252-2440
• Device Lot Number: 18635725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR