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 Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is a combination product.Device code relates to component code.(b)(4).

Event Description

Same case as: mdr id: 2134265-2018-06976.It was reported that 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: the synergy ii us mr 3.50 x 38 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the proximal stent strut rows were damaged with stent struts pushed and bunched, leaving a section of the proximal balloon exposed.The undamaged section of the stent outer diameter was measured and the result 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 signs of damage were noted on the distal edges of the tip.A visual and tactile examination found a hypotube break at 295mm distal from the distal end of the strain relief.Multiple hypotube kinks were also noted along several locations of the hypotube shaft during device examination.A visual and tactile examination of the outer 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 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: mdr id: 2134265-2018-06976.It was reported that 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.

• 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: 7744907
• MDR Text Key: 115888064
• Report Number: 2134265-2018-06975
• 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

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2019
• Device Model Number: H7493926038350
• Device Catalogue Number: 39260-3835
• Device Lot Number: 21657079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention