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

Model Number	H7493952838270
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, 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 mid left anterior descending artery (lad).Diagnostic pictures were taken and percutaneous coronary intervention (pci) was performed.After a 6f fl4 non-bsc guide catheter and a non-bsc guide wire crossed the lesion, a 2.75x20mm synergy ii drug-eluting stent was advanced to the lesion but the physician was not able to get a good picture and so he pulled the stent together with the stent delivery system (sds) back.The physician again advanced the stent but it would not cross.It was then noticed that the stent was no longer on the balloon but on the wire in the ostial/proximal lad and left main artery (lm) undeployed.The physician removed the sds and the stent remained on the wire but undeployed.A 2.0mm apex balloon catheter was then advanced into the undeployed stent and slightly inflated the lesion.The physician planned to drag the stent back into the guide and remove it from the patient's body.However, the stent and the 2.0mm balloon catheter was too large to be pulled into the 6f guide catheter.At this time, the stent was in the lm and partially hanging into the aorta but still on the wire.A 2.75mm apex balloon catheter was used to anchor but not embed the stent in the lm or the aorta.The patient was sent to surgery and is currently in the hospital recovering from double bypass in the left internal mammary artery to the lad and vein graph to the left posterior descending artery.No further patient complications were reported and the patient's status was doing well after the surgery.
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: a promus premier damaged, detached and separated stent was returned without the stent delivery system.Device analysis determined that the condition of the returned device was consistent with the complaint incident as the premier stent was detached and separated.Based on the event description and analysis results stent dislodgement may have occurred during the attempt to withdraw the device.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was further reported that the 2.75x38mm promus premier drug-eluting stent (des) was the correct complaint device relating to the dislodged stent and not the 2.75x20mm synergy ii des as what was previously reported.The promus premier device was pulled back and the physician advanced a synergy ii stent delivery system into the patient.It was during the advancement of the synergy ii stent when the physician noticed that the promus premier stent had actually dislodged from the delivery system and remained on the wire, undeployed.The synergy ii stent delivery system was not advanced any further and was immediately withdrawn and removed from the patient.The physician then advanced the apex balloon catheter in an attempt to remove the dislodged stent.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7331143
• Report Number: 2134265-2018-01616
• Device Sequence Number: 16169230
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/11/2018

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 Model Number: H7493952838270
• Device Catalogue Number: 39528-3827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 02/11/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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: Hospitalization; Required Intervention