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 H7493926020300

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

Patient Problem Prolapse (2475)

Event Date 05/20/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Bsc id: (b)(4).Tw: (b)(4).

Event Description

It was reported that tissue prolapsed occurred.The patient presented with st elevation myocardial infarction (stemi).The in-stent restenosis of previously implanted stent target lesion was located in the proximal left anterior descending artery.A 3.00 x 20mm synergy ii drug-eluting stent was implanted to treat the lesion.However, tissue prolapse "tissue/plaque¿ from the area being stented extruding through the stent struts was noted.Upon post-dilation with a non-bsc balloon catheter, the tissue prolapse of the implanted stent was worsened.To cover the tissue prolapse, the physician then required a second layer stenting and the procedure was completed.No further patient complications were reported and the patient's status was stable/fine.

• 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: 7601308
• MDR Text Key: 111055066
• Report Number: 2134265-2018-05255
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: 08714729840176
• 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
• Report Date: 05/20/2018

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: 03/07/2019
• Device Model Number: H7493926020300
• Device Catalogue Number: 39260-2030
• Device Lot Number: 0021865560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2018
• Initial Date FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2018
• 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