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

Model Number	10602
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The synergy ii us mr 2.50 x 16mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found stent damage with struts in distal region lifted and pulled distally.The stent showed no signs of movement and was set between the proximal and distal marker bands.The undamaged crimped stent od (outer diameter) was measured within maximum 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 tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 01/12/2022.It was reported that crossing difficulties were encountered.The target lesion was located in the mildly tortuous and mildly calcified mid left anterior descending artery which contained a 60 degree bend.The 2.50 x 16 synergy ii drug-euluting stent was advanced for treatment but was unable to cross the target lesion.The procedure was completed successfully with another device.However, device analysis revealed stent damage.
Event or Problem Description
Reportable based on device analysis completed on 01/12/2022.It was reported that crossing difficulties were encountered.The target lesion was located in the mildly tortuous and mildly calcified mid left anterior descending artery which contained a 60 degree bend.The 2.50 x 16 synergy ii drug-eluting stent was advanced for treatment but was unable to cross the target lesion.The procedure was completed successfully with another device.However, device analysis revealed stent damage.The synergy ii us mr 2.50 x 16mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found stent damage with struts in distal region lifted and pulled distally.The stent showed no signs of movement and was set between the proximal and distal marker bands.The undamaged crimped stent od (outer diameter) was measured within maximum 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 tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
The synergy ii us mr 2.50 x 16mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found stent damage with struts in distal region lifted and pulled distally.The stent showed no signs of movement and was set between the proximal and distal marker bands.The undamaged crimped stent od (outer diameter) was measured within maximum 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 tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13261501
• Report Number: 2134265-2022-00295
• Device Sequence Number: 11952224
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: 08714729840091
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 06/11/2022
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0025617202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown