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

Model Number 10603

Device Problems Failure to Advance (2524); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified proximal left anterior descending artery.After dilatation with a balloon was performed, a 3.00 x 20 synergy ii drug-eluting stent was advanced for treatment.However, the device would not deliver past the lesion and it was attempted to push several times.A guide extension catheter was tried to use for support but was unsuccessful.Then, a rotational atherectomy was utilized to modify the calcium to prep the vessel.After rota, the stent was readvanced but it was noticed that the distal end of the stent was damged and looked winged.A 3.0x18mm non-boston scientific stent was used and completed the procedure.No patient complications were reported.

Event Description

It was reported that stent damage occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified proximal left anterior descending artery.After dilatation with a balloon was performed, a 3.00 x 20 synergy ii drug-eluting stent was advanced for treatment.However, the device would not deliver past the lesion and it was attempted to push several times.A guide extension catheter was tried to use for support but was unsuccessful.Then, a rotational atherectomy was utilized to modify the calcium to prep the vessel.After rota, the stent was readvanced but it was noticed that the distal end of the stent was damaged and looked winged.A 3.0x18mm non-boston scientific stent was used and completed the procedure.No patient complications were reported.It was further reported that the distal end of the stent balloon looked inflated even though they did not inflate the balloon.

• 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: 12310529
• MDR Text Key: 266167879
• Report Number: 2134265-2021-10312
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1