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 H7493926024300

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Death (1802); Device Embedded In Tissue or Plaque (3165)

Event Date 07/10/2018

Event Type  Death  

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 Description

It was reported that the patient died.The patient had come in for a rotablation/ percutaneous coronary intervention (pci) of the circumflex.The rotablation procedure was performed successful without any complications.The physician then deployed a 3.0 x 24 synergy ii everolimus-eluting platinum chromium coronary stent system in the mid-proximal circumflex.They went to remove the stent balloon which became stuck half in the stent and half out of the stent.The physician continued to try and dislodge the balloon.The balloon sheared off and became dislodged in the artery.This totally occluded the circumflex artery and the patient begin to decompensate.A heart pump was inserted but the sheared off balloon was not able to be removed from the patient and the patient died.

Manufacturer Narrative

Device evaluated by mfr: the shaft section of the device was returned for analysis.Device analysis confirmed that the balloon section of the device had separated from the delivery system and was not returned, consistent with the reported balloon section becoming dislodged inside the patient.The shaft of the device had broken at the port bond and multiple hypotube kinks were also noted.The hypotube kinks and shaft break were consistent with device manipulation and the application of excessive force when coming in contact with a resistance or an obstruction inside the patient during the procedure.There were no details provided for the anatomy of the patient in the complaint report.There was no tip, stent or balloon returned.As they had separated from the delivery system.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.A visual and tactile examination of shaft polymer extrusion revealed a shaft break at the port bond site.(b)(4).

Event Description

Related to user facility medwatch # 5079388.

• 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: 7740098
• MDR Text Key: 115715691
• Report Number: 2134265-2018-06909
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• 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: 09/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2019
• Device Model Number: H7493926024300
• Device Catalogue Number: 39260-2430
• Device Lot Number: 0021950304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 09/13/2018
• Supplement Dates FDA Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2018
• 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): Death; Required Intervention
• Patient Age: 62 YR