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

Model Number H7493919928220

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Contusion (1763); Chest Pain (1776); Nausea (1970); Reocclusion (1985); Dizziness (2194)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.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

It was reported that myocardial infarction (mi) and in-stent restenosis (isr) occurred.In (b)(6) 2013, clinical status assessment identified that the patient's qualifying condition as unstable angina.Subsequently, the index procedure was performed.Target lesion # 1 was located in the mid right coronary artery (rca) with 90% stenosis, a length of 20 mm, and a reference vessel diameter of 2.25 mm.Target lesion # 1 was treated with pre-dilatation, placement of a 2.25 x 28 mm study stent and post-dilatation with 0% residual stenosis.Target lesion # 2 was located in the distal left circumflex(lcx) artery with 70% stenosis, a length of 15 mm, and a reference vessel diameter of 3.00 mm.Target lesion # 2 was treated with pre-dilatation, and placement of a 3.00 x 20 mm study stent following which the residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient was admitted to the hospital and was diagnosed with st-elevation myocardial infarction (stemi).Cardiac catheterization was recommended which revealed in-stent restenosis of study stent placed in the mid rca and was treated with percutaneous coronary intervention (pci).The patient was also given tenecteplase (tnk) therapy in response to this event.Two days after the event was considered resolved and the patient was discharged.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2017, the patient presented emergently with sudden onset of substernal chest pain radiating to left arm and jaw accompanied by nausea and dizziness.The patient was hospitalized on the same day.At the time of event, therapy with clopidogrel was exchanged to ticagrelor and aspirin was continued.The patient was not on statin therapy.The patient was diagnosed with inferior stemi with complete resolution of st elevation after 45 minutes.The 70% in-stent restenosis was treated with placement of a 3.25x38mm non-bsc stent with 0% residual stenosis and timi 3 flow.

• 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: 6744065
• MDR Text Key: 81038993
• Report Number: 2134265-2017-07867
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: H7493919928220
• Device Lot Number: 15684326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR