MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10603
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the diagonal artery.A 2.50 x 20mm synergy drug-eluting stent was deployed for treatment.However, after deployment, the balloon was noted to be sticking to the stent.After applying negative pressure 4 times it released.No patient complications were reported and patient's prognosis was very good.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 20mm stent delivery system (sds) was returned for analysis without a stent.A hemostatic valve was retuned attached to the hub.The balloon was reviewed.There was no stent on the balloon.The balloon was in a flattened state and appeared to have been inflated and deflated.Visual and tactile examination of the shaft polymer extrusion found no issues.Visual and tactile examination of the hypotube identified no issues.Visual examination of the tip showed no signs of damage.The device was loaded onto a 0.014'' guidewire via tip without issues.The balloon was inflated successfully to rated burst pressure of 16atm.A vacuum was pulled at the balloon deflated fully in 6 seconds.This was within deflation time specification.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the diagonal artery.A 2.50 x 20mm synergy drug-eluting stent was deployed for treatment.However, after deployment, the balloon was noted to be sticking to the stent.After applying negative pressure 4 times it released.No patient complications were reported and patient's prognosis was very good.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8736982
• Report Number: 2134265-2019-06679
• Device Sequence Number: 2637013
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 02/19/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023412431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1