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

Model Number	H7493926024220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the mid left anterior descending artery (lad).A 2.25 x 24mm synergy ii drug-eluting stent was advanced to treat the lesion.Resistance was noted upon delivering the device and upon attempting to inflate the balloon for stent deployment, the stent would not inflate.The inflation device was replaced but still the same issue was noted.The device was completely removed with the stent intact on the balloon.Once the device was completely removed from the patient's body, the distal end of the shaft snapped but was still on the black hypotube portion of the delivery system.The procedure was completed with a 2.25x24mm synergy stent.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.25 x 24mm stent delivery system was returned for analysis.A visual examination of the crimped stent found no issues.There were no signs of damage, lifting or stretching of the stent struts.The 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.The balloon was inflated to rated burst pressure (rbp) using an inflation aid attached to the broken hypotube.The stent deployed without any issues.The balloon was deflated without issues.Deflation time measured and was within the specification.A visual and tactile examination of the device found multiple kinks along the full catheter length.The hypotube was broken at approximately 835mm distal to the distal end of the strain relief.An examination of the shaft polymer extrusion revealed a tear at the guide wire exchange port.Upon inflation attempts the balloon inflated without issue using an inflation aid, there was no leak from the damaged location at the exchange port.The tip was visually and microscopically examined and no issues were noted.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the mid left anterior descending artery (lad).A 2.25 x 24mm synergy ii drug-eluting stent was advanced to treat the lesion.Resistance was noted upon delivering the device and upon attempting to inflate the balloon for stent deployment, the stent would not inflate.The inflation device was replaced but still the same issue was noted.The device was completely removed with the stent intact on the balloon.Once the device was completely removed from the patient's body, the distal end of the shaft snapped but was still on the black hypotube portion of the delivery system.The procedure was completed with a 2.25x24mm synergy stent.No patient complications nor injuries were reported.

• 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 - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7046038
• Report Number: 2134265-2017-11424
• Device Sequence Number: 1851836
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: 08714729840206
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/01/2017

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: 05/23/2018
• Device Model Number: H7493926024220
• Device Catalogue Number: 39260-2422
• Device Lot Number: 20704504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR