MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926220250

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)

Event Date 09/21/2017

Event Type  Death  

Manufacturer Narrative

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#2134265-2017-09964.It was reported that loss of blood pressure, cardiogenic shock, and death occurred.The patient presented with almost no-flow in the right coronary artery (rca).In the physician¿s opinion the patient¿s vessel condition was bad and the patient could not undergo surgery.The 95-99% stenosed target lesion was located in the left anterior descending artery (lad).During the first pre-dilatation with an nc emerge balloon the patient's blood pressure suddenly dropped.The patient was given vasopressors and a 2.5x20mm synergy stent was implanted in the left main over the lad in an attempt to increase the blood flow.The patient's blood pressure did not improve and cardiopulmonary resuscitation was performed for an hour.The patient went into cardiogenic shock and died.

Manufacturer Narrative

(b)(4).Catalog mode# updated.(b)(4).

Event Description

Same case as mdr#2134265-2017-09964.It was reported that loss of blood pressure, cardiogenic shock, and death occurred.The patient presented with almost no-flow in the right coronary artery (rca).In the physician¿s opinion the patient¿s vessel condition was bad and the patient could not undergo surgery.The 95-99% stenosed target lesion was located in the left anterior descending artery (lad).During the first pre-dilatation with an nc emerge balloon the patient's blood pressure suddenly dropped.The patient was given vasopressors and a 2.5x20mm synergy stent was implanted in the left main over the lad in an attempt to increase the blood flow.The patient's blood pressure did not improve and cardiopulmonary resuscitation was performed for an hour.The patient went into cardiogenic shock and died.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6912621
• MDR Text Key: 88104007
• Report Number: 2134265-2017-10152
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: H7493926220250
• Device Catalogue Number: 39262-2025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 09/22/2017
• Supplement Dates FDA Received: 10/20/2017
• 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: 69 YR