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

Model Number H7493926228300

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

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: a synergy ous mr 3.00 x 28mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found no issues.There were no signs of damage or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and the result was within max 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 and tactile examination of the device found that the hypotube was broken 173mm distal to the strain relief with multiple kinks along the full catheter length.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and slight damage was noted.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 device analysis completed on 31-mar-2017.It was reported that crossing difficulties were encountered and shaft kink was encountered.Vascular access was obtained via radial artery.The target lesion was located in the severely tortuous and severely calcified left circumflex (lcx) artery.Following predilation, a non-bsc stent was advanced but failed to cross the lesion.The guide catheter was replaced and a guidezilla guide extension catheter was advanced.A 3.00 x 28 synergy¿ drug-eluting stent was advanced but failed to cross the lesion.Additional dilatation was performed and the guidezilla was replaced with a non-bsc guide extension catheter.The synergy¿ stent was re-advanced but still failed to cross the lesion.Vascular access was changed from radial to femoral artery.Two guide wire was advanced and predilation was performed.The synergy¿ was re-advanced but still failed to cross.It was noted that when the shaft was pushed forcibly, the proximal part of the hub got kinked.The device was removed from the y-connector.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed hypotube break.

• 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: 6494299
• MDR Text Key: 72879594
• Report Number: 2134265-2017-03619
• 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
• Report Date: 03/31/2017

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: 05/22/2018
• Device Model Number: H7493926228300
• Device Catalogue Number: 39262-2830
• Device Lot Number: 20021295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• 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