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

Model Number	10604
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/27/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that a broken stent strut, perforation and death occurred.The target lesion was located in the mid right coronary artery (rca).A 4.00x24mm synergy ii stent was selected for use.During the procedure the synergy stent strut broke.A perforation in the rca was observed.A stent was placed to cover the perforation and was unsuccessful.Patient death occurred after the procedure and prior to discharge.
Event or Problem Description
It was reported that a broken stent strut, perforation and death occurred.The target lesion was located in the mid right coronary artery (rca).A 4.00x24mm synergy ii stent was selected for use.During the procedure the synergy stent strut broke.A perforation in the rca was observed.A stent was placed to cover the perforation and was unsuccessful.Patient death occurred after the procedure and prior to discharge.
Additional Manufacturer Narrative
Evaluation by manufacturer: the device was not returned to the complaint investigation site (cis) therefore device analysis could not be performed.Procedural angiographic media was provided to assist in the investigation and was reviewed by a boston scientific medical director.The rca-pci complicated by vessel perforation (rupture), cardiac tamponade and death.After initial stent deployment the stented vessel was dilated while tethering the stent around the acute margin.The stent material stretched to conform to the vessel thus distorting the cell architecture.As the vessel was overexpanded the hinge point was constrained which yielded the perforation/rupture.The vessel injury extended proximal past the stent margin necessitating a proximal stent for control.The provided images are consistent with the perforation complaint; however, the allegation of broken stent strut is not clearly supported.The stent material deformation likely resulted by anchoring the proximal stent with the remainder of the stent tethered across the acute margin hinge point causing it to stretch to cover the bend.Aggressive dilation of the vessel with the stent across the acute margin may have contributed to the perforation (rupture).Stent deformation and catastrophic vessel injury requiring additional intervention are included in the synergy ii risk management documentation.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12368459
• Report Number: 2134265-2021-10827
• Device Sequence Number: 11845475
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2023
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0027081027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death