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

Model Number H7493926220300

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that balloon leakage occurred.The target lesion was located in the severely calcified proximal left anterior descending artery (lad).A 3.00 x 20mm synergy¿ drug-eluting stent was advanced to treat the lesion.However, during initial dilation at 10 atmospheres for 25 seconds, a contrast agent seeped out from the balloon.The stent was implanted successfully and was well apposed.The stent balloon was pulled out without issue and the procedure was completed.No patient complications were reported and the patient¿s status was stable.

Manufacturer Narrative

Device evaluated by mfr: stent delivery system (sds) was returned for analysis.The stent was not returned for analysis.The balloon body was reviewed and the balloon wings appeared relaxed confirming that positive pressure was applied.As part of the analysis, inflation of the device was attempted.The returned device was attached to an encore inflation device and positive pressure was applied in an attempt to inflate the balloon.The balloon inflated to nominal pressure then subsequently to rated burst pressure without any issues noted and deflated within 6 seconds which is within specification.A visual examination of the bumper tip showed signs of damage at the distal edges of the tip.This type of damage is consistent with excessive force being applied on the delivery system.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied on the delivery system.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied on the delivery system.Visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion shaft.The bicomponent bond showed no signs of damage.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that balloon leakage occurred.The target lesion was located in the severely calcified proximal left anterior descending artery (lad).A 3.00 x 20mm synergy¿ drug-eluting stent was advanced to treat the lesion.However, during initial dilation at 10 atmospheres for 25 seconds, a contrast agent seeped out from the balloon.The stent was implanted successfully and was well apposed.The stent balloon was pulled out without issue and the procedure was completed.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: 6567447
• MDR Text Key: 75176736
• Report Number: 2134265-2017-04731
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2018
• Device Model Number: H7493926220300
• Device Catalogue Number: 39262-2030
• Device Lot Number: 0020126357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• 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