MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Device Problem Material Deformation (2976)

Patient Problem Death (1802)

Event Date 12/01/2019

Event Type  Death  

Manufacturer Narrative

Date of event: the date of the event is unknown. Bsc became aware of the reported event on 10 december 2019. Therefore, a date of 01 december was entered to indicate that the event occurred on an unknown day in (b)(6) 2019.

Event Description

It was reported that stent damage and a patient death occurred. The target lesion was located in a heavily calcified right coronary artery (rca). While attempting to deliver a 3. 00 x 48mm synergy stent to the target lesion, it crumbled. The stent was not inflated and the device was removed. Using a guidezilla, another of the same sized stent was delivered to the target lesion. The procedure was completed without any further complications. However, six hours post the procedure, the patient died. It was noted that the patient death was not related to the stent or the procedure.

• Brand Name: SYNERGY
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 9495080
• Report Number: 2134265-2019-15969
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/10/2019
• 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 Outcome(s): Death