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

Model Number H7493926212220

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

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.: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found the stent was damaged on the three most proximal rows.The stent struts were lifted off their crimped positions.The crimped stent od(outer diameter) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual examination of the bumper tip showed signs of damage at the distal edge of the tip.This type of damages is consistent with excessive force being applied to the delivery system.A visual and tactile examination found multiple kinks on several locations along the hypotube profile.This type of damages is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found a mid-shaft kink 95mm proximal of the port bond.This type of damages is consistent with excessive force being applied to the delivery system.The bi-component bond showed no signs of damage or strain.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 operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on analysis completed on 20mar2017.It was reported that crossing difficulties were encountered and shaft kink occurred.The target lesion was located in the first diagonal branch of left anterior descending (lad) artery.A guide wire crossed towards the target lesion and pre-dilatation was performed with a semi-compliant balloon catheter.A 2.25 x 12mm synergy¿ stent was advanced but failed to cross the lesion.The device was then tried to be delivered together with a non bsc guide extension catheter, but still unable to cross the lesion.The device was removed and it was noted that the shaft got kinked.No patient complications were reported.However, returned device analysis revealed stent damage.

• 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: 6453041
• MDR Text Key: 71487863
• Report Number: 2134265-2017-02916
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2017
• Device Model Number: H7493926212220
• Device Catalogue Number: 39262-1222
• Device Lot Number: 19318063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• 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
• Treatment: GUIDE LINER GUIDE EXTENSION CATHETER