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 H7493926012300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/30/2017

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.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#: 2134265-2017-12551.Evolve short dapt clinical study it was reported that stent jailing occurred.In (b)(6) 2017, clinical status assessment indicated the patient¿s qualifying condition as unstable angina and was referred for elective cardiac catheterization.Subsequently, index procedure was performed.The target lesion was located in the proximal left anterior descending (lad) artery with 80% stenosis and was 12mm long with a reference vessel diameter of 3.00 mm.The lesion was treated with pre-dilatation and placement of a 3.00x12mm synergy ii drug-eluting stent (des) with 0% residual stenosis and timi 3 flow.Post placement of the stent in proximal lad, grade b dissection was noted.On the same day, in response to dissection, another 3.00x12mm synergy ii des was deployed in mid lad.Post deployment of the second stent, the 70% stenosis noted in mid lad was reduced to 0%.Following post deployment of the stent, jailing was noted in ostial second diagonal branch and an attempt was made to treat this jailing.Additionally, on the same day, the 90% ostial stenosis present in first diagonal was treated with percutaneous transluminal coronary angioplasty (ptca).Post ptca, the residual stenosis was 30%.

Manufacturer Narrative

(b)(4).

Event Description

In (b)(6) 2017, it was further reported that stent jailing occurred.Site has confirmed that jailing in first diagonal was due to the study stent deployed in the proximal lad.It was also further reported that the target lesion #2 was located in the mid left anterior descending (lad) with 70% stenosis and was 12 mm long with a reference vessel diameter of 3.00 mm.The stenting in mid lad was due to the dissection and not planned until after the dissection occurred.The synergy ii stent placed for the dissection and the 70% stenosis in the mid lad was a study stent.Site confirmed through mail that there was no percutaneous transluminal coronary angioplasty or stent deployed in second diagonal, only a wire was attempted to cross but was unable to cross in the second diagonal.

• 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: 7129403
• MDR Text Key: 95234272
• Report Number: 2134265-2017-12941
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2018
• Device Model Number: H7493926012300
• Device Catalogue Number: 39260-1230
• Device Lot Number: 20357111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2017
• 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): Other
• Patient Age: 85 YR