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

Model Number H7493926216400

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).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

It was reported that stent thrombosis, patient st elevation and patient chest pain occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).In (b)(6) 2018, the patient presented with acute myocardial infarction and a percutaneous coronary intervention was performed in the left anterior descending.An attempt was made to also treat the right coronary artery lesion but due to severe calcification of 270 degrees, the device could not be inserted.The case was scheduled to perform on a later date.In (b)(6) 2018, the patient presented for treatment of the rca.After placing a non-bsc guide wire and guide catheter, an opticross was not able to be inserted due to the tortuosity and calcification in the mid rca.Ablation was performed with rota 1.25burr-1.5burr.Intravascular ultrasound (ivus) check was performed and it was confirmed that excavation was able to perform and.Following pre-dilatation using a non-bsc balloon catheter, a 4.00 x 16 synergy¿ drug-eluting stent was placed in the proximal to mid rca.The implanted stent did not extend into the aorta.Post dilatation was performed in the proximal part of rca using a non-bsc balloon catheter.Post ivus was perform but the device got caught inside the stent and the image was lost during pullback when the opticross was near mid stent.Angiography was performed and the procedure was completed.Eight days later, lower wall st elevation and chest pain were observed.Angiography revealed a total occlusion at rca total.Aspiration was performed several times and a large amount of white thrombus was removed.Thrombus was confirmed on almost the entire length inside the stent by angiography.Plain old balloon angioplasty was performed and an intra-aortic balloon pump was inserted.The st elevation and chest pain disappeared.No further patient complications were reported and the patient's status was stable.

• 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: 7327669
• MDR Text Key: 102014832
• Report Number: 2134265-2018-01632
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2018

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: 09/05/2018
• Device Model Number: H7493926216400
• Device Catalogue Number: 39262-1640
• Device Lot Number: 0020410192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• 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
• Treatment: GUIDE CATHETER: HYPERION7FJL1; GUIDE WIRE: SION BLUCK SIONBLUE ROTA FLOPPY; INTRODUCER SHEATH: RADIFORCUS
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 42