MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926220300

Device Problem Occlusion Within Device (1423)

Patient Problems Shock (2072); Thrombosis (2100)

Event Date 04/15/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id# 2134265-2016-03040, 2134265-2016-04871, 2134265-2016-03994.It was reported that stent thrombosis occurred.In (b)(6) 2016, the 90% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery (rca).An opticross¿ imaging catheter was selected to visualize the target lesion.Upon removal of the opticross¿ imaging catheter, resistance was encountered.It was noticed that the opticross¿ imaging catheter was entangled with a guidewire.The physician then inserted another guidewire, changed bias then withdrew the opticross¿ imaging catheter.It was further noticed that the guidewire exit port of the opticross¿ imaging catheter was deformed and the guidewire was kinked.The procedure continued with another opticross¿ imaging catheter.During the procedure, resistance was encountered during withdrawal and a minor dissection occurred in the proximal to mid rca.The dissection is believed to have been caused by the opticross¿ imaging catheters or the unknown guidewire coming into contact with the vessel.No additional treatment for the dissection was performed.At an unspecified time during the procedure, the physician encountered difficulty crossing the lesion with the guide wire.A balloon catheter was used to dilate a 99% stenosis in the distal rca.A 3.0x20mn synergy stent was deployed.From the distal rca to the right posterior descending artery )pda) thrombus was confirmed; however, the physician was unable to deliver a suction catheter due to the vessel tortuosity, so the physician elected to perform dilatation with a balloon catheter.During dilation, the patient was in a state of shock.The physician elected to deploy a 2.5x38mm synergy stent in the right pda to treat the 100% occlusion.The physician was concerned that additional dilatation may cause worsening of the patient¿s symptoms.The stent was expanded to 2.5mm.Timi 3 flow was noted and the procedure completed.In (b)(6) 2015, angiography was performed to check the condition of the dissection and it was confirmed that the dissection had healed.100% thrombotic occlusion was noted in the previously implanted synergy stents.The physician expanded the blocked area with a balloon catheter.The 2.5x38mm synergy stent had incomplete expansion for the vessel diameter.A2.5x28 non-bsc stent was implanted.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5664905
• MDR Text Key: 45469451
• Report Number: 2134265-2016-04135
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2017
• Device Model Number: H7493926220300
• Device Catalogue Number: 39262-2030
• Device Lot Number: 18657526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR