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

Model Number H7493926216250

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).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 mdr will be filed.(b)(4).

Event Description

It was reported that catheter removal difficulties and deflation issues occurred.The target lesion was located in the right coronary artery.A 2.50 x 16 synergy¿ stent was selected to treat the lesion.However, the stent system balloon got stuck and could not be remove from the stent.While the balloon remained inflated, the patient experienced low blood pressure.The balloon had to be deflated a few times before it was removed and inserted an emerge balloon catheter which was inflated at low atmospheres.It took 5 minutes to remove the device completely which delayed the procedure for 15 minutes more.The procedure was completed with a different device.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: synergy ous mr 2.50 x 16mm stent delivery system (sds); a section of the device was returned for analysis without the hub and catheter number attached.No stent returned.Stent separated from sds.The balloon was reviewed.There was no stent on the balloon.The distal balloon section appeared creased, the balloon appeared to not be fully deflated.Functional testing of the balloon could not be performed due to device condition.No hypotube returned.Shaft broken and not returned for analysis.No shaft returned.A visual and microscopic examination of the tip found no damage.No other issues were identified during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).

Event Description

It was reported that catheter removal difficulties and deflation issues occurred.The target lesion was located in the right coronary artery.A 2.50 x 16 synergy stent was selected to treat the lesion.However, the stent system balloon got stuck and could not be remove from the stent.While the balloon remained inflated, the patient experienced low blood pressure.The balloon had to be deflated a few times before it was removed and inserted an emerge balloon catheter which was inflated at low atmospheres.It took 5 minutes to remove the device completely which delayed the procedure for 15 minutes more.The procedure was completed with a different device.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: 7727110
• MDR Text Key: 115253169
• Report Number: 2134265-2018-06817
• 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
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: H7493926216250
• Device Catalogue Number: 39262-1625
• Device Lot Number: 21711103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• 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