MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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

Patient Problems Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that hypotension and atrial fibrillation occurred.On an unspecified date, a couple of months ago, multiple layers of stents were placed.The patient presented with restenosis of the previously implanted stents.Vascular access was attempted via the radial artery prior to access being obtained via the femoral artery.The target lesion was located in the mid left anterior descending artery (lad).After a 3.5mm non-bsc guide catheter and another non-bsc wire were used to cross the lesion, an emerge balloon catheter was advanced for dilatation.The wire knuckled going down.A 3.00 x 16mm synergy ii drug-eluting stent was implanted in the mid lad.A 3.0x12mm nc quantum balloon catheter was advanced for post dilatation but the device failed to cross.A 3.0x12mm non-bsc balloon was advanced and post dilation was performed.The stent looked fine but there did seem to be a tight lesion in the proximal circumflex.The cardiologist did attempt radial prior to femoral approach.There was a possible perforation or dissection in the brachial area.The patient was in stable condition and went to recovery.Twenty to thirty minutes post stent deployment, the patient experienced st elevation and chest pain and was brought back to the lab.Vascular access was obtained via the left groin.Thrombosis was noted in proximal lad to distal area.The lad was wired and ballooned and the flow was restored.A possible distal dissection was noted and additional synergy stents were implanted to cover the dissection with timi 3 flow post procedure.The patient was unstable with low blood pressure and atrial fibrillation.The patient was placed on three pressures and synchronized cardioverted.The patient was transferred to cardiovascular intensive care unit in critical condition.The patient was still conscious and alert on bilevel positive airway pressure.No further patient complications were reported and the patient was stable.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7906573
• MDR Text Key: 121619815
• Report Number: 2134265-2018-61267
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR