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	H7493926012400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
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 dislodgment occurred.The target lesion was located in a severely tortuous and severely calcified coronary artery.A 4.00 x 12 synergy ii drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent came off the balloon and was caught up in the lesion.The dislodged stent was then trapped in the touhy and was able to be removed from there without any other additional intervention performed.The procedure was completed with another 4.00 x 12 synergy ii drug-eluting stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.00 x 12mm stent delivery system (sds) was returned for analysis with a detached stent.A visual and microscopic examination of the crimped stent identified that the stent was damaged and had been separated from the delivery device.The stent was damaged; struts at the proximal end of the stent were lifted.The balloon was reviewed.There was no stent on the balloon.The balloon wings were relaxed; the balloon appeared to have been subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip found damage to the distal edge of the tip.No other issues were identified during the product analysis.There is no evidence that the device failed to meet specification.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 dislodgment occurred.The target lesion was located in a severely tortuous and severely calcified coronary artery.A 4.00 x 12 synergy ii drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent came off the balloon and was caught up in the lesion.The dislodged stent was then trapped in the touhy and was able to be removed from there without any other additional intervention performed.The procedure was completed with another 4.00 x 12 synergy ii drug-eluting stent.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: 6739023
• Report Number: 2134265-2017-07752
• Device Sequence Number: 1566079
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: (01)08714729840077(17)20170726(10)19549232
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2017
• Device Model Number: H7493926012400
• Device Catalogue Number: 39260-1240
• Device Lot Number: 19549232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention