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 H7493926028400

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was not received for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported via medwatch# (b)(4) that stent dislodgement occurred.The target lesion was located in the saphenous vein graft.A 4.00x28mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The device was removed and re-advanced several times due to inability in cross the lesion.At one point during removal, it was noticed that the stent was no longer mounted on the balloon, but sitting in the ostium of the vein graft.Soon, thereafter, it became mobile and ended up lodging itself in a branch of the of the left renal artery.Vascular surgery was considered however, physician doubted that the patient the patient would have any sequelae from this and patient would still have normal renal function.Additionally, attempting endovascular retrieval would likely cause more complications.Successful percutaneous coronary intervention was performed in the saphenous vein graft, right coronary artery and left circumflex with synergy stents.No further patient complications and no untoward effects were reported.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6855215
• MDR Text Key: 85644415
• Report Number: 2134265-2017-08956
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: (01)08714729840312(17)20180426(10)20612001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/21/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2018
• Device Model Number: H7493926028400
• Device Catalogue Number: 39260-2840
• Device Lot Number: 20612001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR