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

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: (b)(6) 2016.Age at time of event: 18 years old or older.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# 2134265-2016-12488.It was reported that angina and in-stent restenosis (isr) occurred.In (b)(6) 2016, the patient underwent percutaneous coronary intervention (pci) for a lesion located in the proximal to distal right coronary artery (rca).Two synergy¿ drug-eluting stent were implanted to treat the lesion.Following post-dilatation with a 4.0mm non-compliant balloon catheter, the stents were very well apposed.The procedure was completed with great results.In (b)(6) 2016, the patient presented with sudden increase of angina and angiogram was performed.Angiogram revealed the two synergy¿ stents had significant isr.Subsequently, the isr was reopened using non-compliant balloon catheters and a scoring balloon, and was treated with a non-bsc paclitaxel-eluting balloon catheter.The procedure was completed with no further patient complications reported.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6199610
• MDR Text Key: 63133044
• Report Number: 2134265-2016-12487
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2016

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 Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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