MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926012220

Device Problems Break (1069); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Intimal Dissection (1333); Death (1802); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Complete Heart Block (2627)

Event Date 08/15/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product. (b)(4).

Event Description

Same case as mdr id# 2134265-2017-09176 & 2134265-2017-09177. It was reported that stent dislodgement, shaft break and difficulty removing the catheter occurred. Then, a dissection was noted and the patient was sent to surgery. Fourteen days later, the patient presented with st elevated myocardial infarction (stemi), third degree heart block, thrombosis and died one day post re-intervention. The target lesion was located in the mid right coronary artery (rca). A 2. 25 x 12 synergy stent and a 2. 25 x 16 synergy stent were implanted in the distal rca and the physician was attempting to deliver another 2. 25 x 12 synergy stent, however, difficulty advancing in the mid rca was noted. As the physician was pulling the stent back into the guide catheter, resistance was felt and as he continue to pull back he noticed the stent stayed in the ostium of the rca and the shaft continued to pull back. When the delivery system was out of the body, he realized that the distal 8 inches of the shaft were broken off, part in the artery and part in the guide catheter. A non bsc guide extension catheter was positioned into the area and was used to re-capture the broken shaft and pull it out. The dislodged stent was deployed against the wall in the right ostial artery. After this, a dissection was noted in the rca. The vessel could not be re-wired and the patient was sent to bypass surgery. The surgery went well and the patient was doing very well. Fourteen days later, the patient presented with stemi and third degree heart block. In the cath lab, it was noted that the saphenous vein graft was full of thrombus. Three non-bsc stents were placed in the saphenous vein graft and at the end of the procedure there was a timi 1 flow down the vessel. Patient was brought upstairs to her room in a "critically ill" status and died the following morning. The cause of death was acute hemorrhage. The physician does not believe the patient death is related to the synergy stents.

Manufacturer Narrative

Synergy ii, us, 2. 25 x 12mm stent delivery system was returned for analysis. The device was returned in two sections (as a break occurred on the proximal end of the port weld) the first section containing the balloon, tip, inner/outer shaft polymer extrusion and port weld and the second section included a broken midshaft, kinked hypotube and undamaged manifold. The stent was not returned for analysis with the device as it was deployed during the procedure. The balloon cones & balloon main body were reviewed and analysis suggests that the balloon had been subjected to positive pressure. The balloon wings were opened out from their folded positions and crimp markings were evident on the balloon wall indicating that there was crimp contact between the coated stent and balloon at the time of manufacture. There was evidence of dried medium (resembling blood) inside the balloon body. The proximal bond was reviewed and there were no issues noted. A visual and tactile examination of the mid-shaft found a break 129mm distal of the midshaft/hypotube bond or the break was located on the proximal side of the port weld 240mm from the edge of the distal tip. There was no visible stretching at the midshaft break point. The corewire was exposed. The synergy tab (which is located at the end of the hypotube) was twisted 360 degrees around the corewire and protruded 2. 5mm proximal to where the midshaft break occurred. No visible damage or stretching of the port weld and the port weld channel appeared normal. There was evidence of dried medium (resembling blood) inside the inner/outer extrusion lumen. A visual and tactile was performed on the inner/outer polymer extrusion and a slight kink was noted on the inner extrusion 45mm proximal of the bi-component weld. There was no sign of damage or stretching on the bi-component weld. It is most likely that the midshaft extrusion broke due to the force applied on the delivery system during the withdrawal process however, this cannot be confirmed. A visual and tactile examination found multiple hypotube kinks along the full catheter length. This type of damage is consistent with excessive force being applied to the delivery system. A visual and tactile examination found damage to the tip. The type of damage evident is consistent with resistance being encountered during advancement of the device. No other issues were identified during the product analysis. The review of the manufacturing processes concluded that there were no issues or anomalies noted during the production of finished goods batch (b)(4), catheter batch (b)(4). The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

Event Description

Same case as mdr id# 2134265-2017-09176 & 2134265-2017-09177. It was reported that stent dislodgement, shaft break and difficulty removing the catheter occurred. Then, a dissection was noted and the patient was sent to surgery. Fourteen days later, the patient presented with st elevated myocardial infarction (stemi), third degree heart block, thrombosis and died one day post re-intervention. The target lesion was located in the mid right coronary artery (rca). A 2. 25 x 12 synergy stent and a 2. 25 x 16 synergy stent were implanted in the distal rca and the physician was attempting to deliver another 2. 25 x 12 synergy stent, however, difficulty advancing in the mid rca was noted. As the physician was pulling the stent back into the guide catheter, resistance was felt and as he continue to pull back he noticed the stent stayed in the ostium of the rca and the shaft continued to pull back. When the delivery system was out of the body, he realized that the distal 8 inches of the shaft were broken off, part in the artery and part in the guide catheter. A non bsc guide extension catheter was positioned into the area and was used to re-capture the broken shaft and pull it out. The dislodged stent was deployed against the wall in the right ostial artery. After this, a dissection was noted in the rca. The vessel could not be re-wired and the patient was sent to bypass surgery. The surgery went well and the patient was doing very well. Fourteen days later, the patient presented with stemi and third degree heart block. In the cath lab, it was noted that the saphenous vein graft was full of thrombus. Three non-bsc stents were placed in the saphenous vein graft and at the end of the procedure there was a timi 1 flow down the vessel. Patient was brought upstairs to her room in a "critically ill" status and died the following morning. The cause of death was acute hemorrhage. The physician does not believe the patient death is related to the synergy stents.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6857720
• MDR Text Key: 85764066
• Report Number: 2134265-2017-08798
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/07/2018
• Device Model Number: H7493926012220
• Device Catalogue Number: 39260-1222
• Device Lot Number: 20776528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/12/2017 Patient Sequence Number: 1

Treatment

GUIDE CATHETER: MEDTRONIC AL.75, 6F