MAUDE Adverse Event Report: BOSTON SCIENTIFIC EVEROLIMUS SYNERGY MONORAIL 2.5 MM X 38 MM; CORONARY STENT SYSTEM

Catalog Number H7493926038250

Device Problems Fracture (1260); Material Rupture (1546); Sticking (1597); Material Protrusion/Extrusion (2979)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2017

Event Type  Injury  

Event Description

Procedure being performed: left heart cath with coronary angiography and rotational atherectomy with pci.During the deployment, balloon ruptured before even reaching nominal pressure and upon trying to remove the balloon, the hypotube attached to the delivery balloon and stent fractured leaving the stent/balloon embedded in the coronary.A guidewire was advanced and the balloon/stent wire system was carefully withdrawn into the guideline and the entire system was removed.Although the proximal edge of the stent caught the edge of the sheath and was partially stuck inside the right of a sheath.Interventional radiology was notified to assist with the removal of the fragmented catheter.The fractured catheter fragment was protruding from the right groin sheath.It was gently pulled into the left groin sheath and the sheath hub was removed.The piece was recovered intact.There were no further complications.

• Brand Name: EVEROLIMUS SYNERGY MONORAIL 2.5 MM X 38 MM
• Type of Device: CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC; quincy MA 02171
• MDR Report Key: 6541092
• MDR Text Key: 74425821
• Report Number: MW5069527
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2017
• Device Catalogue Number: H7493926038250
• Device Lot Number: 20072404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 57