MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926038220

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Atrial Fibrillation (1729); Congestive Heart Failure (1783); Dyspnea (1816); Fatigue (1849); Occlusion (1984); Reocclusion (1985); Chest Tightness/Pressure (2463)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.The device was not returned for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

(b)(4) clinical study.It was reported that angina and coronary restenosis occurred.In (b)(6) 2016, clinical status assessment revealed the patient's qualifying condition as stable angina and the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the proximal left circumflex (lcx) artery with 99% stenosis and was 12mm long with a reference vessel diameter of 2.25mm.The target lesion was treated with pre-dilatation and placement of 2.25x38mm synergy ii study stent.Following post-dilatation, the residual stenosis was 0%.On the same day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the site reported an event of class iii angina.Nine days later, the 89% stenosis in proximal lcx was treated with drug-eluting stent placement, post which residual stenosis was 0%.Subsequently, an interventional procedure was also performed in response to the event.On the same day, the event was considered resolved.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the target lesion was a long lesion located in the proximal/mid lcx to the second obtuse marginal (om2).In (b)(6) 2017, chronic atrial fibrillation was noted.Nine days after, focal in-stent restenosis at the proximal edge in mid lcx stent was noted and treated.The non-bsc stent in the mid lcx jailed the ostium of om1 and a 2.75x12mm non-bsc stent was implanted in an overlapping manner.There was small stenosis at the distal edge of 3.5 x 28 mm non-bsc stent which was treated with balloon angioplasty with good angiographic result.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2017, the patient came with the complaints of chest pressure and dyspnea on exertion, fatigue and class ii chronic heart failure (chf).The patient was referred for cardiac catheterization with possible percutaneous coronary intervention (pci) to assess ischemic induced chf and stent restenosis.Eight days later, 80-89% stenosis in mid left circumflex (lcx) was treated with pre-dilatation and placement of 2.75 x 12 mm non-bsc drug eluting stent.Following post dilatation, the residual stenosis was 0% with timi 3 flow.Post stent deployment in mid lcx, stenosis in om1 got worsened to 80% which was treated with pre-dilatation and placement of 3.5 x 28 mm non-bsc stent.Following post dilatation, the residual stenosis was 0% with timi 3 flow.Patient was sent home with discharge instructions.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 6899745
• MDR Text Key: 87589878
• Report Number: 2134265-2017-09504
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2017
• Device Model Number: H7493926038220
• Device Catalogue Number: 39260-3822
• Device Lot Number: 19472110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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: 67 YR