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	H7493926016400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the femoral artery.A 4.00 x 16 mm synergy ii drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent came off the balloon right at the end of the sheath in the femoral artery.The stent had to be retrieved by accessing the other groin.Eventually, the stent was able to be retrieved and another of the same stent was deployed and completed the procedure.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the stent delivery system (sds) was not returned for analysis therefore the catheter batch/serial number cannot be identified.A visual examination of the crimped stent found that the stent was detached/separated from the delivery system and damaged its entire length.Hardened medium resembling blood/tissue was attached to some of the stent struts.The sds was not returned for analysis therefore reviews for individual assessment of the catheter could not be performed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the femoral artery.A 4.00x16mm synergy ii drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent came off the balloon right at the end of the sheath in the femoral artery.The stent had to be retrieved by accessing the other groin.Eventually, the stent was able to be retrieved and another of the same stent was deployed and completed the procedure.No patient complications were reported and the patient's status was fine.However, returned device analysis revealed stent detached/separated and stent damaged.

• 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: 7733167
• Report Number: 2134265-2018-06844
• Device Sequence Number: 1588973
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• 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): 07/10/2018

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: 03/20/2019
• Device Model Number: H7493926016400
• Device Catalogue Number: 39260-1640
• Device Lot Number: 21927571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/03/2018
• 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