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

Model Number H7493926232250

Device Problems Bent (1059); Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

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 obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent inadequate apposition, stent migration, and stent damage occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 2.50 x 32mm synergy drug-eluting stent was advanced to treat the lesion.However, upon deployment, the stent was not fully expanded.When the stent delivery balloon was moved to the proximal part of the stent, the stent got caught in the balloon and was stretched about 15mm towards the proximal area.The procedure was completed and the missed lesion remained uncovered.No 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: 7279417
• MDR Text Key: 100391233
• Report Number: 2134265-2018-00928
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2018
• Device Model Number: H7493926232250
• Device Catalogue Number: 39262-3225
• Device Lot Number: 20370549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• 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 Age: 69 YR