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

Model Number	10605
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties and device break occurred.The patient presented with multiple layers of stents already with significant in-stent restenosis of the entire very tortuous and calcified right coronary artery.The vessel was prepped with pre-dilatations, cutting balloons, and rotablator.Stents were placed from the distal end and a guide dissection was noted in the ostium.A 4.00 x 28mm synergy drug-eluting stent was placed in the proximal/ostium with no issues.The stent balloon was pulled back to post dilate the ostium to 5mm.The balloon expanded and deflated just fine.When the doctor tried to remove the balloon from the patient, the balloon would not move.The balloon was inflated again and it went up and back down fine, but it still would not move.The balloon was expanded and deflated once more, but this time when an attempt was made to remove the device, the balloon snapped off the shaft and the shaft came out of the body leaving the balloon in the vessel.An attempt was made to snare the balloon but when it failed, the patient was brought to surgery for another physician to assess.Because the balloon could not be snared and the patient was not a surgical candidate, the decision was made to jail the balloon by sandwiching it with another stent.A 4.0x28mm stent was deployed to ensure everything was covered.Post dilation and intravascular ultrasound were performed.The patient had good flow and was fine overnight.
Event or Problem Description
It was reported that removal difficulties and device break occurred.The patient presented with multiple layers of stents already with significant in-stent restenosis of the entire very tortuous and calcified right coronary artery.The vessel was prepped with pre-dilatations, cutting balloons, and rotablator.Stents were placed from the distal end and a guide dissection was noted in the ostium.A 4.00 x 28mm synergy drug-eluting stent was placed in the proximal/ostium with no issues.The stent balloon was pulled back to post dilate the ostium to 5mm.The balloon expanded and deflated just fine.When the doctor tried to remove the balloon from the patient, the balloon would not move.The balloon was inflated again and it went up and back down fine, but it still would not move.The balloon was expanded and deflated once more, but this time when an attempt was made to remove the device, the balloon snapped off the shaft and the shaft came out of the body leaving the balloon in the vessel.An attempt was made to snare the balloon but when it failed, the patient was brought to surgery for another physician to assess.Because the balloon could not be snared and the patient was not a surgical candidate, the decision was made to jail the balloon by sandwiching it with another stent.A 4.0x28mm stent was deployed to ensure everything was covered.Post dilation and intravascular ultrasound were performed.The patient had good flow and was fine overnight.It was further reported via medwatch that four non-bsc stents had been deployed and the cutting balloons were wolverine.The patient had timi-3 flow post procedure and that no adverse physiological effects were noted during or after the event.
Additional Manufacturer Narrative
Device is a combination product.

• 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: 9191978
• Report Number: 2134265-2019-12360
• Device Sequence Number: 2409651
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 11/11/2019
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022969992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: ABBOTT XIENCE SIERRA DES (FOUR TOTAL)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 79