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

Model Number H7493926216400

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.The target lesion was located in the severely tortuous mid right coronary artery.A 4.00 x 16 synergy¿ drug-eluting stent was advanced but had difficulties crossing the lesion.The device was removed and it was noted that the proximal edge of the stent struts was lifted.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.  device evaluated by mfr.: stent delivery system was returned for analysis.A visual examination of the stent found that the stent was damage across the entire stent length with most severe damage at the proximal end - proximal stent struts were bunched in distal direction.The stent had moved distally on the balloon, leaving part of the proximal balloon body exposed and covering the distal markerband.The maximum crimped stent outer diameter at the time of manufacture 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.The tip was visually and microscopically examined and no signs of damage were noted.A visual and tactile examination found no kinks or damage along the hypotube shaft.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 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

It was reported that stent damage occurred.The target lesion was located in the severely tortuous mid right coronary artery.A 4.00 x 16 synergy¿ drug-eluting stent was advanced but had difficulties crossing the lesion.The device was removed and it was noted that the proximal edge of the stent struts was lifted.The procedure was completed with a different device.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
• MDR Report Key: 7627960
• MDR Text Key: 111986238
• Report Number: 2134265-2018-05816
• 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
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

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: 06/18/2019
• Device Model Number: H7493926216400
• Device Catalogue Number: 39262-1640
• Device Lot Number: 21554424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1