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 H7493926008250

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problem Chest Pain (1776)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

Complainant name: (b)(6) medical center.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 Description

Same case as mdr id: 2134265-2017-01106 and 2134265-2017-01107.It was reported that stent dislodgment and chest pain occurred.The patient presented with chest pain.The long target lesion was located in the mid to distal circumflex artery.Two synergy drug-eluting stents were deployed to treat the lesion.An additional 2.50 x 8 synergy ii drug-eluting stent was advanced but failed to cross the lesion and the device was removed.The lesion was then dilated and the 2.50 x 8 synergy ii stent was advanced again but it still failed to cross the lesion and the device was removed.However, after the device was removed, the stent was no longer on the balloon and could not be located anywhere.The distal portion was only treated with plain old balloon angioplasty and the procedure was completed.The patient's chest pain persisted and the patient was kept overnight.No further patient complications were reported and the patient's status was fine.The patient has been discharged.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr, device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: a stent delivery system was returned for analysis.The stent had detached from the delivery system and was not returned for analysis.The tip was visually and microscopically examined and slight damage was noted at the distal edge of the tip.This type of damage is consistent with excessive force being applied to the delivery system.The balloon body was reviewed and no issues were noted with the overall balloon.Crimp markings were evident on the balloon wall verifying that the stent was crimped on the balloon before stent detachment.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-01106 and 2134265-2017-01107.It was reported that stent dislodgment and chest pain occurred.The patient presented with chest pain.The long target lesion was located in the mid to distal circumflex artery.Two synergy¿ drug-eluting stents were deployed to treat the lesion.An additional 2.50 x 8 synergy ii drug-eluting stent was advanced but failed to cross the lesion and the device was removed.The lesion was then dilated and the 2.50 x 8 synergy ii stent was advanced again but it still failed to cross the lesion and the device was removed.However, after the device was removed, the stent was no longer on the balloon and could not be located anywhere.The distal portion was only treated with plain old balloon angioplasty and the procedure was completed.The patient's chest pain persisted and the patient was kept overnight.No further patient complications were reported and the patient's status was fine.The patient has been discharged.

• 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: 6331681
• MDR Text Key: 67479934
• Report Number: 2134265-2017-01105
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729839972
• UDI-Public: (01)08714729839972(17)20170505(10)19253277
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2017
• Device Model Number: H7493926008250
• Device Catalogue Number: 39260-0825
• Device Lot Number: 19253277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2016
• 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): Required Intervention
• Patient Age: 69 YR