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

Model Number	H7493952816350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
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 that stent dislodgment occurred.The patient presented with non-st segment elevation myocardial infarction (nstemi), active chest pain, and elevated troponin levels.The target lesion was located in the tortuous mid right coronary artery (rca).After two promus premier¿ stents were implanted, a 3.50x16mm promus premier¿ drug-eluting stent was advanced to further treat the lesion.After vigorous attempts to advance the stent, it was determined that the area needed dilatation.However, when removal of the device was attempted, the stent dislodged from the delivery system and remained wedged in the proximal rca.The dislodged stent was able to be removed using a snare after repeated attempts.The procedure was completed with a different device with no patient complications reported and the patient's status was fine.The patient has been discharged.
Additional Manufacturer Narrative
Age at time of event corrected from (b)(6) to (b)(6).(b)(4).
Event or Problem Description
It was further reported via user/facility medwatch (b)(4) that the stent dislodged while in the right coronary (rca) artery and migrated to the aorta before it was retrieved.Additional treatment was given to the patient including medications, prolonged procedure, x-ray and intubation to prevent excess movement.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6188990
• Report Number: 2134265-2016-11978
• Device Sequence Number: 377250
• Product Code: NIQ
• UDI-Device Identifier: 08714729844747
• UDI-Public: (01)08714729844747(17)20170905(10)19054254
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/06/2016

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: 09/05/2017
• Device Model Number: H7493952816350
• Device Catalogue Number: 39528-1635
• Device Lot Number: 19054254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 02/23/2017
• 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: Required Intervention
• Patient Age: 66 YR