MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926038220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/21/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred and the patient died.The patient presented for rotational atherectomy and percutaneous coronary intervention (pci) in left anterior descending (lad) artery.No reflow situation was observed.A 2.25 x 38 synergy ii everolimus-eluting platinum chromium coronary stent system was advanced but failed to cross the lesion.When the device was attempted to be removed, the stent came off the balloon and was found in the proximal guide catheter.The physician had to remove the entire catheter with the stent stuck in catheter.The patient passed shortly after the procedure, but it was not believed to be related in any way to stent dislodgement.
Additional Manufacturer Narrative
Last name corrected from (b)(6).Describe event or problem : updated.Device evaluated by mfr: visual inspection of the returned device revealed the stent delivery system (sds) was not returned for analysis.The crimped stent was returned inside a guide catheter.The guide catheter was cut 120 mm distal from the distal end of the strain relief.The guide catheter was then cut again 70 mm distal from the distal end of the strain relief.The guide catheter was then cut open and the stent was found inside.The stent was damaged its entire length and distal stent rows 3-4 were fractured.The stent was also covered in hardened medium resembling blood.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause classification of this investigation is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-09001 and 2134265-2017-09003.It was further reported that rotational atherectomy was performed with rotablator.The lesion was then pre-dilated and a synergy stent was implanted.The stent was then post-dilated.The patient went into an arrhythmia.Contrast injection was performed and no flow was observed in the lad.The patient began to crash.Chest compressions were performed, the patient was intubated, and a left ventricular assist device was implanted.Another 2.25 x 38 synergy stent was attempted to be implanted in the distal lad; however it was not able to cross the lad and was removed.The physician attempted another balloon but it would not advance into the guide.It was then noted the stent had dislodged in the hub of the guide catheter.The procedure was stopped and the patient was taken to the icu on life support, but in "stable" condition.The patient passed away a few hours later in the icu.The dislodged stent was not related to the patient complications and outcome.An autopsy has not been performed.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6772881
• Report Number: 2134265-2017-07889
• Device Sequence Number: 821943
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: (01)08714729840381(17)20171006(10)19853172
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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): 07/21/2017

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: 10/06/2017
• Device Model Number: H7493926038220
• Device Catalogue Number: 39260-3822
• Device Lot Number: 19853172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 08/25/2017
• 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: Death
• Patient Age: 81 YR