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 H7493926038250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cardiogenic Shock (2262)

Event Date 03/07/2018

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id #: 2134265-2018-02588, 2134265-2018-02589, 2134265-2018-02590, 2134265-2018-02591, 2134265-2018-02592, 2134265-2018-02593, 2134265-2018-02628, 2134265-2018-03162, 2134265-2018-03163, 2134265-2018-03164, 2134265-2018-03165, 2134265-2018-03166, 2134265-2018-03168, 2134265-2018-03169, 2134265-2018-03173.It was reported that the patient died post procedure.The patient presented from hospice care.The patient was intubated and had a non-bsc heart pump in place.The target lesions were a chronic total occlusion of the right coronary artery (rca), the left anterior descending artery (lad) and the severely tortuous circumflex.Seventeen boston scientific products were used throughout the procedure.The physician started with the circumflex and experienced a vessel perforation caused by a non-bsc guidewire.The perforation was minimal and was not treated.The lad and left main arteries were successfully stented with 2.50x38mm, 3.00x38mm and 3.50x16mm synergy stents and balloon angioplasty was performed.At that point, the patient¿s pressure and heart rate were both dropping.The heart rate was increased with pacing and the procedure was ended.The patient was sent from the catheterization lab to the floor where he expired some hours later during the night.The cause of death is cardiogenic shock.

• 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: 7383656
• MDR Text Key: 103908746
• Report Number: 2134265-2018-03167
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Report Date: 03/07/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: H7493926038250
• Device Catalogue Number: 39260-3825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR