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	H7493926016270
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.75x16mm synergy ii stent was advanced to treat the target lesion.However, after deploying the stent, the balloon ruptured at 16 atmospheres.The device was completely removed.Post-dilatation was performed using a non-compliant balloon and the procedure was completed.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: stent delivery system was returned for analysis.The stent was deployed in the patient and therefore not returned for analysis.The tip was visually and microscopically examined and no damage was noted.The balloon cones were reviewed and no issues were noted.The balloon wings appeared relaxed from their original folded position and it appeared that positive pressure was applied and a vacuum pulled.The balloon was inflated with no issues.The balloon deflated within specification as per the directions for use.The encore inflation device was verified before and after use.A visual and tactile examination of the device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the inner and outer lumen and mid-shaft section found no issues along the shaft polymer extrusion.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 not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.75x16mm synergy ii stent was advanced to treat the target lesion.However, after deploying the stent, the balloon ruptured at 16 atmospheres.The device was completely removed.Post-dilatation was performed using a non-compliant balloon and the procedure was completed.No patient complications were reported and the patient's status was fine.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7545009
• Report Number: 2134265-2018-04625
• Device Sequence Number: 13504100
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: 08714729840107
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2019
• Device Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Device Lot Number: 21753324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1