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

Model Number	10601
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy ii us mr 3.50 x 28mm stent delivery system was returned for analysis.A visual examination of the stent identified stent damage.Proximal stent strut row 1 was lifted and damaged.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip identified damage.A visual and tactile examination of the hypotube identified multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section identified inner polymer extrusion twisting and damage 55mm proximal from distal end of tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 14nov2019.A 3.50 x 28 synergy drug-eluting stent was opened and was noted to be defective.However, returned device analysis revealed stent damaged.
Event or Problem Description
Reportable based on device analysis completed on 14nov2019.A 3.50 x 28 synergy drug-eluting stent was opened and was noted to be defective.However, returned device analysis revealed stent damaged.
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy ii us mr 3.50 x 12mm stent delivery system was returned for analysis.A visual examination of the stent identified stent damage.Proximal stent strut row 1 was lifted and damaged.The undamaged crimped stent outer diameter was measured within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip identified damage.A visual and tactile examination of the hypotube identified multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section identified inner polymer extrusion twisting and damage 55mm proximal from distal end of tip.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
• MDR Report Key: 9444008
• Report Number: 2134265-2019-14628
• Device Sequence Number: 2243131
• Product Code: NIQ
• UDI-Device Identifier: 08714729840305
• UDI-Public: 08714729840305
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 04/22/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0023723305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1