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

Device Problem Activation Failure (3270)

Patient Problem Perforation (2001)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event:used the first day of the month of the bsc aware date.Event date not provided.Device is a combination product.

Event Description

It was reported that stent mal apposition and perforation occurred.The target lesion was located in the left anterior descending artery (lad).A rotablator was used in the proximal lad and a 3.0 synergy ii drug-eluting stent was implanted in the proximal to mid lad.However, the mid to distal area where the rota was performed had recoiled and angiographic distortion of the stent was noted.A 3.0 nc balloon catheter was advanced for post-dilatation but the stent would recoil upon deflation of the balloon.Atmospheric pressure was increased to rated, however, perforation occurred.A pericardiocentesis was performed and the balloon was inflated for a long period of time.The patient stabilized and no further perforation was noted.The patient was discharged without any additional issues.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10010755
• MDR Text Key: 189695845
• Report Number: 2134265-2020-05011
• 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: 04/29/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/29/2020
• 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