MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10605
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon rupture and removal difficulties occurred.The target lesion was located in the left anterior descending artery.A 2.75 x 28mm synergy ii drug-eluting stent was advanced to treat the lesion.However, when negative pressure was applied with the indeflator, it was noted in the hub of the delivery catheter as well as in the indeflator tubing, that the balloon ruptured.The physician was unable to pull the stent back into the guide, so the wire, stent delivery catheter, and guide were removed.Another 2.75x28mm synergy stent was deployed and the procedure was completed.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.75 x 28 mm stent delivery system was returned for analysis.A visual examination of the stent found that the proximal end of stent was damaged with stent struts bunched distally and the distal end of stent was also damaged with stent struts pulled distally.The undamaged stent od (outer diameter) was measured within maximum crimped stent profile measurement.Stent damage most likely occurred during withdrawal attempts.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 microscopic examination of the bumper tip showed no signs of damage.The device was returned loaded in guide catheter with a 0.070'" guidewire in the wire lumen of the device.The hypotube shaft was not visible.As part of analysis an attempt was made to inflate the device to rbp (rated burst pressure) however the device-maintained pressure but failed to inflate.The device was soaked in the water-bath to soften hardened medium that could have blocked the wire lumen.After attempting to inflate again it was observed that the device was leaking from the guide catheter.The device was cut 15 mm distal from the distal end of the strain relief to remove the device through the tip of the guide catheter and a visual and tactile examination of the hypotube found a hypotube break at 670 mm distal from the distal end of the strain relief.This type of damage is consistent with excessive force that could have been applied on the delivery system during advancing attempts.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues with the extrusion shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture and removal difficulties occurred.The target lesion was located in the left anterior descending artery.A 2.75 x 28mm synergy ii drug-eluting stent was advanced to treat the lesion.However, when negative pressure was applied with the indeflator, it was noted in the hub of the delivery catheter as well as in the indeflator tubing, that the balloon ruptured.The physician was unable to pull the stent back into the guide, so the wire, stent delivery catheter, and guide were removed.Another 2.75x28mm synergy stent was deployed and the procedure was completed.No patient complications were reported and the patient's status was stable.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8179042
• Report Number: 2134265-2018-64350
• Device Sequence Number: 13852649
• Product Code: NIQ
• UDI-Device Identifier: 08714729840282
• UDI-Public: 08714729840282
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2019
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0021815222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1