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

Model Number	10603
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties occurred.The patient presented with coronary artery disease (cad).The target lesion was located in the non-tortuous and non-calcified right coronary artery (rca).A 4.00 x 20 synergy drug-eluting stent was advanced and deployed for treatment.The balloon of the stent delivery system (sds) was inflated at 11 atmospheres and was deflated.However, during removal, it was noted that the sds would not retract into the guide catheter despite multiple inflation and deflation of the balloon.The fully deflated balloon delivery system and guide catheter were removed together.The procedure was completed with a new guide catheter and wire.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that removal difficulties occurred.The patient presented with coronary artery disease (cad).The target lesion was located in the non-tortuous and non-calcified right coronary artery (rca).A 4.00 x 20 synergy drug-eluting stent was advanced and deployed for treatment.The balloon of the stent delivery system (sds) was inflated at 11 atmospheres and was deflated.However, during removal, it was noted that the sds would not retract into the guide catheter despite multiple inflation and deflation of the balloon.The fully deflated balloon delivery system and guide catheter were removed together.The procedure was completed with a new guide catheter and wire.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy ii us mr 4.00 x 20 m stent delivery system (sds) was returned for analysis without the stent and inside the customer hemostatic valve, 6f bsci guide catheter and on the customer guidewire.The device was returned without the stent as it was deployed successfully at the lesion site.The balloon and distal section of the device was stuck on customer guidewire and the whole system was also stuck inside the guide catheter.The whole system was soaked to allow for removal of the delivery system.The system could not be however withdrawn/ advanced in the guide, the guide catheter was cut intentionally to expose the delivery system.Soft sticky substance present inside the guide catheter.The outer of the device was damaged while cutting the guide.The balloon cones were reviewed, and signs of negative pressure were noted however the balloon wings were folded and appeared consistent with withdrawal through a device.No bunching was noted on the balloon.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a stretching damage on the inner shaft polymer extrusion 2 mm distally to the bicomponent bond.Additionally, several tears were noted on the outer shaft polymer extrusion caused by the investigator while cutting the guide.An inflation attempt was made using an encore device to the rated burst pressure, however zero pressure could be sustained in the inflation device due to leaks from the outer tears.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: 12616522
• Report Number: 2134265-2021-12555
• Device Sequence Number: 19172676
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: 08714729840190
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: 08/12/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0025901096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• 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