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

Model Number	10605
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00 x 28mm synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the stent was hung up on some calcium and a guide extender was placed in the artery.When the synergy was pulled back, the stent came off and lodged in the artery and had to be snared to retrieve.This caused the procedure to be extended for a long time.The procedure was completed with another of same device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00 x 28mm synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the stent was hung up on some calcium and a guide extender was placed in the artery.When the synergy was pulled back, the stent came off and lodged in the artery and had to be snared to retrieve.This caused the procedure to be extended for a long time.The procedure was completed with another of same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device is a combination product.Synergy ii us mr 3.00 x 28 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found that the stent was dislodged from the balloon and damaged.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was 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.Crimp markings were noted on the exposed balloon body.A visual and microscopic examination of the bumper tip showed signs of damage at the distal end of the tip.A visual and tactile examination of the hypotube shaft found multiple kinks 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 no issues.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: 9760317
• Report Number: 2134265-2020-02183
• Device Sequence Number: 13579178
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0024248168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention