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

Model Number	10601
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent partial deployment occurred.The target lesion was located in a graft in the right coronary artery.A 4.00 x 12mm synergy drug-eluting stent was advanced for treatment.However, upon placement, it was noted that the only half of the stent was deployed.The stent was completely removed with a snare and the procedure was completed with a new stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 12 mm stent delivery system was returned for analysis.The returned stent was not attached to the device.The entire stent was damaged.The stent outer diameter was within maximum crimped stent profile measurement.Positive pressure appeared to have been applied to the balloon as it was returned in a deflated state.The distal end of the balloon appeared bunched.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer lumen and mid- shaft section found no issues.A visual examination of the inner lumen identified damage at 138cm distal from the distal end of the strain relief as the inner lumen appeared bunched.The balloon was successfully inflated to rated burst pressure without issue.The balloon did not fully deflate when the pressure was released.The inflation device was verified before and after.A recommended 0.014" guidewire failed to track past the inner shaft polymer extrusion damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent partial deployment occurred.The target lesion was located in a graft in the right cornary artery.A 4.00 x 12mm synergy drug-eluting stent was advanced for treatment.However, upon placement, it was noted that the only half of the stent was deployed.The stent was completely removed with a snare and the procedure was completed with a new stent.There were no patient complications reported.

• 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: 8789556
• Report Number: 2134265-2019-07802
• Device Sequence Number: 2665752
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: 08714729840077
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 08/27/2019

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: 11/11/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022959327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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