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

Model Number H7493926216220

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in a coronary vessel.A 2.25 x 16 synergy¿ drug eluting stent was advanced but failed to cross the lesion.The device was removed and it was noted that the distal edge of the stent strut was lifted.The procedure was completed with another synergy stent.No patient complications nor injuries were reported.

• 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: 7575119
• MDR Text Key: 110279903
• Report Number: 2134265-2018-05127
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: H7493926216220
• Device Catalogue Number: 39262-1622
• Device Lot Number: 0021597781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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