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

Model Number	10607
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.A 2.25x38mm synergy ii drug-eluting stent was loaded onto a non-bsc guide wire and was advanced towards the touhy.However, it was noted that the device was locked up on the wire and would not go forward or backwards because the wire was too dry.When the device was pulled on, the shaft broke about 25 cm from the distal tip.The procedure was completed with another synergy stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.:synergy ii us mr 2.25 x 38 mm stent delivery system was returned for analysis broken in 2 sections with the distal section of the device stuck on the customer's guidewire.An examination (visual and via scope) of the crimped stent found stent damage.The proximal to mid stent regions of the stent were bunched and pulled in a distal direction.The undamaged crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.The balloon was reviewed, and signs of damage were noted with the proximal balloon cone bunched in a distal direction.No issues were noted with the distal balloon cone as its wings were noted to be tightly folded.A visual and microscopic examination of the bumper tip showed signs of damage on the distal end of the tip.A visual and tactile examination of the hypotube shaft noted multiple kinks were along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found multiple stretching/bunching regions of the inner and outer shaft polymer extrusion.A break was also noted in the shaft polymer extrusion located in the port bond region at 23.7 cm proximal to the distal end of the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.A 2.25x38mm synergy ii drug-eluting stent was loaded onto a non-bsc guide wire and was advanced towards the touhy.However, it was noted that the device was locked up on the wire and would not go forward or backwards because the wire was too dry.When the device was pulled on, the shaft broke about 25 cm from the distal tip.The procedure was completed with another synergy stent.There were no patient complications reported.

• 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: 9369670
• Report Number: 2134265-2019-14099
• Device Sequence Number: 14002560
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/22/2020

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 Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024072302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1