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

Model Number	10606
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in the averagely tortuous and severely calcified mid right coronary artery.After a staged rotablator, the lesion was dilated with an emerge balloon catheter without issues, but upon removal from the patient's body the shaft then snapped 1/3 from the hub inside the 8fr guide catheter.The wire was pulled back into the guide catheter and snared the broken shaft without removing the guide catheter.The lesion then dilated with a different balloon catheter.A 2.50 x 32 synergy drug-eluting stent was advanced but failed to cross and so another balloon was used to pre-dilate the lesion.The 2.50 x 32 stent was advanced for the second time but the shaft broke at the mid portion of the catheter while advancing into the guide.The stent was pulled out from the guide catheter without removing the device from it.The procedure was completed with a different device.No patient complications were reported and the patient remained stable all throughout the procedure.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 32 mm stent delivery system was returned for analysis.An examination of the crimped stent found stent damage.Stent struts from the most distal region of the stent were noted to be lifted from their crimped position and pulled proximally.The undamaged crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.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 found a break situated at 463 mm distal to the distal end of the strain relief as well as multiple hypotube kinks immediately distal and proximal to the breaking site.A visual and tactile examination of the outer and mid-shaft section nd a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in the averagely tortuous and severely calcified mid right coronary artery.After a staged rotablator, the lesion was dilated with an emerge balloon catheter without issues, but upon removal from the patient's body the shaft then snapped 1/3 from the hub inside the 8fr guide catheter.The wire was pulled back into the guide catheter and snared the broken shaft without removing the guide catheter.The lesion then dilated with a different balloon catheter.A 2.50 x 32 synergy drug-eluting stent was advanced but failed to cross and so another balloon was used to pre-dilate the lesion.The 2.50 x 32 stent was advanced for the second time but the shaft broke at the mid portion of the catheter while advancing into the guide.The stent was pulled out from the guide catheter without removing the device from it.The procedure was completed with a different device device.No patient complications were reported and the patient remained stable all throughout the procedure.

• 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: 9915287
• Report Number: 2134265-2020-04011
• Device Sequence Number: 11448575
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/19/2020

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 Expiration Date: 10/22/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0024694099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1