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

Model Number H7493926224350

Device Problem Occlusion Within Device (1423)

Patient Problems Bradycardia (1751); Myocardial Infarction (1969); Thrombosis (2100); Chest Tightness/Pressure (2463)

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: device not returned therefore analysis of complaint device could not be performed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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

It was reported that myocardial infarction and stent thrombosis occurred.In (b)(6) 2017, clinical status assessment indicated the patient's qualifying condition as stable angina and was further referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the proximal right coronary artery (rca) with 90% stenosis and was 20.0 mm long with a reference vessel diameter of 3.50 mm.The target lesion was treated with pre-dilation and placement of 3.50 x 24 mm study stent, following which residual stenosis was 25%.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient was diagnosed with myocardial infarction and the patient was hospitalized on the same day.The patient was referred for cardiac catheterization.The 100% stenosis in previously placed 3.50 x 24 study stent in proximal rca was treated with placement of drug-eluting stent in which the residual stenosis was 0%.Twelve days after, the event was considered to be recovered/resolved and the patient was discharged on the same day.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that on (b)(6) 2017, nicorandil was initiated.On the following day, the intra-aortic balloon pump was removed and the patient's condition requiring noradrenaline to maintain blood pressure continued.Three days after, the administration of noradrenaline was discontinued.Eight days later, the patient was discharged on dual antiplatelet therapy.

Manufacturer Narrative

Bsc id: (b)(4), tw: (b)(4).

Event Description

Same case as mdr id: 2134265-2017-08156.Evolve short dapt clinical study.It was further reported that in stent restenosis of a previously implanted taxus stent was successfully treated with pre-dilation and placement of a 3.50 x 24mm study stent.It was placed in a way to overlap from the mid portion of the taxus stent.An extra-dilation was performed at the proximal stenotic site with drug coated balloon.In (b)(6) 2017, the patient presented with chest tightness and was hospitalized on the same day.Percutaneous coronary intervention (pci) was recommended and thrombus aspiration was performed in the ostium which led to decrease in stent thrombosis and timi improved to 2.Massive thrombus was observed from ostial to distal for which another aspiration was performed.Aspiration caused a shift to bradycardia which was treated with external pacemaker placement and intra-aortic balloon pump (iabp) insertion with administrating atropine.Timi improved to 3.Subsequent intravascular ultrasound (ivus) revealed huge calcified plaque on the lining in the stent where the lesion was observed.At this stent additional dilatation was performed.Subsequently, total occlusion in proximal rca was treated with pre-dilation and placement of 3.5 x 26mm non-bsc stent.Additionally thrombus aspiration and iabp was performed.

Manufacturer Narrative

Date rec'd by mfr.Corrected from 07/12/2017 to 07/26/2017.Bsc id: (b)(4).Tw: (b)(4).

Event Description

Same case as mdr id: 2134265-2017-08156.Evolve short dapt clinical study.It was further reported that instent restenosis of a previously implanted taxus stent was successfully treated with pre-dilation and placement of a 3.50 x 24mm study stent.It was placed in a way to overlap from the mid portion of the taxus stent.An extra-dilation was performed at the proximal stenotic site with drug coated balloon.In (b)(6) 2017, the patient presented with chest tightness and was hospitalized on the same day.Percutaneous coronary intervention (pci) was recommended and thrombus aspiration was performed in the ostium which led to decrease in stent thrombosis and timi improved to 2.Massive thrombus was observed from ostial to distal for which another aspiration was performed.Aspiration caused a shift to bradycardia which was treated with external pacemaker placement and intra-aortic balloon pump (iabp) insertion with administrating atropine.Timi improved to 3.Subsequent intravascular ultrasound (ivus) revealed huge calcified plaque on the lining in the stent where the lesion was observed.At this stent additional dilatation was performed.Subsequently, total occlusion in proximal rca was treated with pre-dilation and placement of 3.5 x 26mm non-bsc stent.Additionally thrombus aspiration and iabp was performed.

Manufacturer Narrative

Describe event or problem updated.Bsc id: (b)(4).

Event Description

It was further reported that in (b)(6) 2017, plain old balloon angioplasty (poba) was performed in the stent distal portion for the restenosis in the taxus liberte stent and not for the de novo lesion and a 3.50 x 25mm study stent was deployed at the proximal right coronary artery (rca).On the following day, the patient was discharged on aspirin and clopidogrel.

• 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: 6753412
• MDR Text Key: 81371073
• Report Number: 2134265-2017-07627
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2017

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: 07/02/2017
• Device Model Number: H7493926224350
• Device Catalogue Number: 39262-2435
• Device Lot Number: 0018782535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 07/12/2017; 07/26/2017; 08/17/2017; 04/02/2018
• Supplement Dates FDA Received: 08/04/2017; 08/08/2017; 09/05/2017; 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR