MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926038350

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Same case as mdr id: 2134265-2018-06975.It was reported that stent dislodgement occurred inside the sheath and a shaft break occurred.The target lesion was located in a peripheral limb.A 3.50 x 38 mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the shaft broke and hemostats were used to pull the broken part from the sheath.A new 3.50 x 38 mm synergy ii drug-eluting stent was advanced with the support of guidezilla guide extension catheter; however, the shaft broke and upon removal and the stent dislodged in the sheath.The device was removed in its entirety.Angioplasty was performed and the procedure was completed.No patient complications were reported and the patient status was fine.

Event Description

Same case as mdr id: 2134265-2018-06975.It was reported that stent dislodgement occurred inside the sheath and a shaft break occurred.The target lesion was located in a peripheral limb.A 3.50 x 38mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the shaft broke and hemostats were used to pull the broken part from the sheath.A new 3.50 x 38mm synergy ii drug-eluting stent was advanced with the support of guidezilla guide extension catheter; however, the shaft broke and upon removal and the stent dislodged in the sheath.The device was removed in its entirety.Angioplasty was performed and the procedure was completed.No patient complications were reported and the patient status was fine.

Manufacturer Narrative

Device evaluated by mfr: synergy ii us mr 3.50 x 38mm 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 entire stent; the distal end of the stent was damaged and pulled over the tip.The proximal end of the stent is damaged and bunched over the distal balloon cone.The stent had moved distally along the balloon.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 along the full length of the catheter and a hypotube break 840mm distal from the distal end of the strain relief.A visual and tactile examination of shaft polymer extrusion revealed a tear at the wire exchange port, stretching along the port bond and multiple tears and scratching along the shaft polymer extrusion.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).

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7744875
• MDR Text Key: 115905255
• Report Number: 2134265-2018-06976
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

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: 03/12/2019
• Device Model Number: H7493926038350
• Device Catalogue Number: 39260-3835
• Device Lot Number: 0021919657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1