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

Model Number 10605

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent was damaged upon removal.The target lesion was in the severely tortuous and calcified proximal, mid and distal right coronary artery.A 4.00x28 and 4.00x16 synergy drug eluting stent were used for treatment together with the guidezilla guide extension catheter.During the procedure, two synergy stents were deployed in the vessel and a non-bsc stent was used distal to the two synergy.Subsequently, the 4.00x28 stent was placed into the vessel but could not advance to the distal lesion.The stent was removed from the body and it was noted to be unraveled.Then, a 4.0x16 stent was advanced in the guidezilla however it could not pass the transition part of the guidezilla.The stent delivery system was able to be removed but the stent was stuck in the shaft of the co-pilot tuohy.The procedure was completed with a different device.No complications were reported and there was no harm to the patient.

Manufacturer Narrative

Device is a combination product.Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the returned stent found that it was damaged on its entire length but not expanded.The damage consisted of a stretching of all except 4 strut rows located at one end of the stent.A manufacturing crimps stent data was performed and since the stent delivery system was not returned with the stent all 595 results recorded during crimping were reviewed.All devices passed the crimping measurement test with results within max crimped stent profile measurement.The balloon, tip of the device, hypotube shaft and shaft polymer extrusion could not be reviewed as they were not returned.No other issues were identified during the product analysis.

Event Description

It was reported that stent was damage upon removal.The target lesion was in the severely tortuous and calcified proximal, mid and distal right coronary artery.A 4.00x28 and 4.00x16 synergy drug eluting stents were used for treatment together with the guidezilla guide extension catheter.During the procedure, two synergy stents were deployed in the vessel and a non-bsc stent was used distal to the two synergy stents.Subsequently, the 4.00x28 stent was placed into the vessel but could not advance to the distal lesion and got unraveled when removed from the patient's body.Then, a 4.0x16 stent was advanced in the guidezilla however it could not pass the transition part.The stent delivery system was able to be removed but the stent was stuck in the shaft of the co-pilot tuohy.The procedure was completed with a different device.No complications reported and there was no harm on the patient.It was further reported that there was resistance on both issues.The first synergy would not pass through the newly deployed two synergy stents as it may have been getting caught on the other struts.The other synergy stent would not pass through the collar of the guidezilla.There was no problem noted with the guidezilla during advancement and removal.

• 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
• MDR Report Key: 10135394
• MDR Text Key: 194547431
• Report Number: 2134265-2020-07553
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022734901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1