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

Model Number H7493926220350

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).Synergy ous mr 3.50 x 20mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent revealed damage.Proximal strut segments 1-6 were undamaged; the remainder of the struts were damaged and stretched in a distal direction with struts extending over the distal markerband and tip.The crimped stent od (outer diameter) was measured and the result was within specification.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 revealed multiple hypotube kinks.An examination of the shaft polymer extrusion revealed 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 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 07-dec-2017.It was reported that crossing difficulties were encountered.The target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 3.50 x 20 synergy¿ drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a 3.5 x 22 non-bsc stent.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: 7134918
• MDR Text Key: 95665497
• Report Number: 2134265-2017-12603
• 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: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2018
• Device Model Number: H7493926220350
• Device Catalogue Number: 39262-2035
• Device Lot Number: 20830439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• 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