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

Model Number H7493926224250

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in the large diagonal sub-branch of the coronary artery.Following aggressive pre-dilatations, a 2.50 x 24 synergy¿ stent was unsuccessful.Upon removal of the device, it was observed that there was disarrangement of the proximal segment.The procedure was completed with another 2.50 x 24 synergy¿ stent which was successfully implanted.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: synergy ous mr 2.50 x 24mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Damage was noted to the proximal section of the stent; the most proximal stent strut row was damaged and lifted from the stent profile.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 no issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found no 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

It was reported that stent damage occurred.The target lesion was located in the large diagonal sub-branch of the coronary artery.Following aggressive pre-dilatations, a 2.50 x 24 synergy stent was unsuccessful.Upon removal of the device, it was observed that there was disarrangement of the proximal segment.The procedure was completed with another 2.50 x 24 synergy stent which was successfully implanted.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: 7620721
• MDR Text Key: 111896272
• Report Number: 2134265-2018-05454
• 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: 05/28/2018

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: 08/08/2018
• Device Model Number: H7493926224250
• Device Catalogue Number: 39262-2425
• Device Lot Number: 0020285538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 10/07/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1