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

Model Number H7493926212300

Device Problems Premature Activation (1484); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that premature deployment of stent occurred.A 3.00x12 synergy drug-eluting stent was selected for use to treat the lesion.However, during preparation upon removal of the stylet, the stent delivery system balloon was already inflated.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: synergy ous, mr 3.0 x 12mm stent delivery system (sds) was returned for analysis.The stent had detached from the balloon and was not returned with the sds.Further information was requested on how the stent detached however none was made available.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were relaxed and were not subjected to positive pressure.Crimp markings were evident on the exposed part of the balloon wall indicating crimp contact between the coated stent and balloon.A visual and tactile examination found several hypotube kinks along the full catheter length.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issues with the shaft polymer extrusion profile, there was evidence of medium inside the inner /outer lumen.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found no damage to the tip.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that premature deployment of stent occurred.A 3.00x12 synergy drug-eluting stent was selected for use to treat the lesion.However, during preparation upon removal of the stylet, the stent delivery system balloon was already inflated.No patient complications 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5762666
• MDR Text Key: 48622851
• Report Number: 2134265-2016-05675
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 06/07/2016

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: 07/16/2017
• Device Model Number: H7493926212300
• Device Catalogue Number: 39262-1230
• Device Lot Number: 18836191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• 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