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

Model Number H7493926212400

Device Problems Kinked (1339); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: synergy ous mr 4.00 x 12mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified stent damage.Strut rows 4-7 from the proximal end of the stent were damaged and bunched.The remainder of the stent was undamaged.The crimped stent outer diameter was measured and 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 and tactile examination of the hypotube revealed a break at approximately 95mm distal from the distal end of the strain relief.Multiple hypotube kinks were noted.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 no issues were found.No other issues were identified during the product analysis.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 21-aug-2017.It was reported that advancing difficulties were encountered and shaft kink occurred.Vascular access was obtained via the right radial artery.The 80% stenosed, 8x4mm, concentric and de novo target lesion was located in the severely tortuous and moderately calcified mid right coronary artery (rca).The lesion contained a bend between 45 and 95 degree.After 6f jr 3.5 non-bsc guide catheter was engaged in the rca ostium coaxially and a non-bsc guidewire was advanced to the lesion, pre-dilation was performed with a 2.5x9 maverick balloon catheter, leaving 40% residual stenosis in the lesion.A 4.00 x 12 synergy¿ drug-eluting stent was advanced but did not track the bend and when attempted to maneuver, the proximal shaft was kinked and could not be pushed further.The physician removed the device and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube break and 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: 6850807
• MDR Text Key: 85352312
• Report Number: 2134265-2017-08838
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2017
• Device Model Number: H7493926212400
• Device Catalogue Number: 39262-1240
• Device Lot Number: 18705002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2015
• 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 Age: 54 YR