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	H7493926032250
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(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 stent move on balloon occurred.The target lesion was located in the calcified circumflex (cx) artery to the left main (lm) artery.After a non bsc guidewire has crossed the lesion, a 2.5 x 20 emerge¿ balloon catheter was advanced and pre-dilated the lesion with good result.Subsequently, a 2.50 x 32 synergy ii stent was advanced but just at the bifurcation of the cx to lm there appeared to be a lot of calcium that was not visible on the angiography.The stent failed to cross the lesion and during removal of the device, resistance was felt.The physician continued to pull and when the device passed through the tuohy it was discovered that the stent had moved on the balloon.The procedure was completed with 3 non-bsc stents which also had trouble crossing but ended up implanted with good results.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.50 x 32mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found the stent was damaged along its entire length and separated from the sds.There was no stent on the balloon.The balloon folds were tightly wrapped and evenly folded and were not subjected to positive pressure.Stent crimp markings were evident on the exposed balloon wall indicating correct positioning and crimping of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion profile revealed no issues.A visual and microscopic examination of the tip found no issues.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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent move on balloon occurred.The target lesion was located in the calcified circumflex (cx) artery to the left main (lm) artery.After a non bsc guidewire has crossed the lesion, a 2.5 x 20 emerge¿ balloon catheter was advanced and pre-dilated the lesion with good result.Subsequently, a 2.50 x 32 synergy ii stent was advanced but just at the bifurcation of the cx to lm there appeared to be a lot of calcium that was not visible on the angiography.The stent failed to cross the lesion and during removal of the device, resistance was felt.The physician continued to pull and when the device passed through the tuohy it was discovered that the stent had moved on the balloon.The procedure was completed with 3 non-bsc stents which also had trouble crossing but ended up implanted with good results.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: 6500146
• Report Number: 2134265-2017-04113
• Device Sequence Number: 13638156
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: (01)08714729840336(17)20171003(10)19807725
• 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): 04/10/2017

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: 10/03/2017
• Device Model Number: H7493926032250
• Device Catalogue Number: 39260-3225
• Device Lot Number: 19807725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RUNTHROUGH GUIDE WIRE
• Patient Age: 83 YR