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

Model Number H7493926238400

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device is a combination product.(b)(4).Device evaluated by mfr: stent delivery system was returned for analysis.A visual examination of the stent found that the stent was damaged on the proximal section with stent struts misaligned.The undamaged distal section of the crimped stent outer diameter was 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.The tip was visually and microscopically examined and no signs of damage were noted.A visual and tactile examination found multiple kinks along several locations of the proximal portion of the hypotube.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the extrusion shaft.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on 22may2018.It was reported that shaft kink occurred.The 90% target lesion was located in the severely tortuous and severely calcified right coronary artery.After a non-bsc guide wire crossed the lesion and pre-dilatation was performed with a 2.0 x 15mm non-bsc balloon catheter, a 4.00 x 38 synergy¿ stent was advanced for treatment.However, due to angulation when crossing the lesion, it was noted that the shaft was kinked.The procedure was completed with a 4.0x38mm non-bsc stent.No patient complications were reported and the patient¿s status was stable.However, device analysis revealed proximal 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: 7605603
• MDR Text Key: 111194578
• Report Number: 2134265-2018-05107
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2018
• Device Model Number: H7493926238400
• Device Catalogue Number: 39262-3840
• Device Lot Number: 19873203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• 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
• Treatment: BALLOON CATHETER: GENOSS 2.0*15MM; GUIDEWIRE: FIELDER XT G/W
• Patient Age: 58 YR