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

Model Number	10602
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulty occurred.The target lesion was located in the non tortuous and moderately calcified right coronary artery.The physician placed a 3.5 x 38mm synergy drug-eluting stent (des) and post dilated it with a 4.0 x 20 nc emerge balloon catheter.A 4.00 x 16 synergy des was advanced in the proximal part of the previously placed stent.However, difficulties were encountered in getting the stents to overlap but was deployed eventually at 18 atmospheres.The balloon was deflated and then extreme difficulties upon removing the device.After the device was removed from the patient's body, the stent was still on the balloon.The procedure was completed without placing any stent.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulty occurred.The target lesion was located in the non tortuous and moderately calcified right coronary artery.The physician placed a 3.5 x 38mm synergy drug-eluting stent (des) and post dilated it with a 4.0 x 20 nc emerge balloon catheter.A 4.00 x 16 synergy des was advanced in the proximal part of the previously placed stent.However, difficulties were encountered in getting the stents to overlap but was deployed eventually at 18 atmospheres.The balloon was deflated and then extreme difficulties upon removing the device.After the device was removed from the patient's body, the stent was still on the balloon.The procedure was completed without placing any stent.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 16 mm stent delivery system was returned for analysis inside a guide catheter with two guidewires and a haemostatic valve.Device was returned inside a guide catheter with the distal portion of the balloon and a damaged stent on a guidewire visible outside the tip of the guide catheter.Device was advanced forward without issue to view balloon, which was in a deflated state.Resistance felt during attempt to withdraw device, following soaking in a water-bath the device was removed from the guide catheter without issue.A visual examination of the stent found evidence of damage.The stent is detached from the balloon and the entire length of the stent is stretched and damaged on a guidewire.The balloon cones were reviewed, and the balloon wings were relaxed, and it was evident that the balloon had been subjected to positive and negative pressure.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found multiple kinks along the polymer extrusion shaft and inner lumen damage 140.7cm distal to distal end of strain relief.The balloon was inflated to its rated burst pressure without issue.The device was deflated without issue in 8 seconds which is within deflation time specification.The inflation device was verified before and after use.A recommended 0.014 inch guide wire was introduced into the device to facilitate the functional testing.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: 8604494
• Report Number: 2134265-2019-04939
• Device Sequence Number: 16881041
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/25/2019

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: 01/07/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023203545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1