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

Model Number H7493926228220

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Same case as mfr report#: 2134265-2017-12465.It was reported that stent damage occurred.During the procedure, a 2.25x28mm synergy drug-eluting stent was advanced to treat the very tortuous and moderately calcified lesion.A small resistance was felt while positioning the stent.After the stent was withdrawn in order to dilate the lesion again, open struts of the stent were noted.Thus another 2.25x28mm synergy drug-eluting stent was advanced to treat the lesion, but there was resistance advancing the device and the stent became damaged.The procedure was completed with another same device.No patient complications were reported and the patient¿s status was stable.

Manufacturer Narrative

Device evaluated by mfr: synergy ous mr 2.25 x 28mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Distal stent rows 4-8 were damaged with stent struts stretched and deformed.The undamaged 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 hypotube found multiple hypotube kinks.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found damage to the tip.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

Same case as mfr report#: 2134265-2017-12465.It was reported that stent damage occurred.During the procedure, a 2.25x28mm synergy drug-eluting stent was advanced to treat the very tortuous and moderately calcified lesion.A small resistance was felt while positioning the stent.After the stent was withdrawn in order to dilate the lesion again, open struts of the stent were noted.Thus another 2.25x28mm synergy drug-eluting stent was advanced to treat the lesion, but there was resistance advancing the device and the stent became damaged.The procedure was completed with another same 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
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7131467
• MDR Text Key: 95534415
• Report Number: 2134265-2017-12464
• 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,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2019
• Device Model Number: H7493926228220
• Device Catalogue Number: 39262-2822
• Device Lot Number: 20909243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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
• Patient Age: 77 YR