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

Model Number 10618

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

Patient Problems Atrial Fibrillation (1729); Death (1802)

Event Date 05/20/2019

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that the patient died.The patient presented with poor left ventricular (lv) function and needs to undergo percutaneous coronary intervention (pci).The physician decided to do the pci with intra-aortic balloon pump (iabp).The target lesion was located in a coronary artery.The lesion was treated with stent implantation using 2.50x48mm and 3.0x16mm synergy drug-eluting stents and the procedure was completed.Post procedure, the patient felt better.Since the patient's lv function still not good enough, the iabp was kept in his body and was observed.Four days later, the patient died due to atrial fibrillation and no time to rescue.

Event Description

It was reported that the patient died.The patient presented with poor left ventricular (lv) function and needs to undergo percutaneous coronary intervention (pci).The physician decided to do the pci with intra-aortic balloon pump (iabp).The target lesion was located in a coronary artery.The lesion was treated with stent implantation using 2.50x48mm and 3.0x16mm synergy drug-eluting stents and the procedure was completed.Post procedure, the patient felt better.Since the patient's lv function still not good enough, the iabp was kept in his body and was observed.Four days later, the patient died due to atrial fibrillation and no time to rescue.It was further reported that the 2 synergy stents did not contribute to the patient's death because the patient has a very poor lv function and it was confirmed that patient died due to heart failure.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8691561
• MDR Text Key: 147738701
• Report Number: 2134265-2019-05680
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0022878608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2018
• 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
• Patient Age: 72 YR