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

Model Number	H7493952832400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2017
Type of Reportable Event	Malfunction
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
Same case as mdr id: 2134265-2017-01716.It was reported that the stent moved on the balloon.The target lesion was located in the right coronary artery (rca).A 4.00x32mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent bunched up in the middle of the balloon and slid a couple of millimeters off the end of the balloon.The proximal end of the stent was half way down the balloon.To prevent the stent to be dislodged from the balloon, the physician deployed the stent to where it was.The physician then dilated the first stent after it was deployed.The physician advanced a 4.00x16mm promus premier¿ drug-eluting stent but there was difficulty passing through the first deployed stent.While pulling the second stent out, it hung up on the first stent and the first stent hung up on the guide.The second stent had a burr in the middle of the stent.A non-bsc guide extension catheter was then advanced and another promus stent was delivered which completed the procedure.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6385270
• Report Number: 2134265-2017-01671
• Device Sequence Number: 317017
• Product Code: NIQ
• UDI-Device Identifier: 08714729844990
• UDI-Public: (01)08714729844990(17)20170716(10)18847182
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/14/2017

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: 07/16/2017
• Device Model Number: H7493952832400
• Device Catalogue Number: 39528-3240
• Device Lot Number: 18847182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/07/2017
• 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