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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10605
Device Problem Break (1069)
Patient Problem Embolism (1829)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.Age: (b)(6).
 
Event Description
It was reported that shaft break and embolization occurred.The patient presented with chest pain, rising troponins, and electrocardiogram changes which is consistent with ischemia.The target lesion was located in the left anterior descending artery (lad) and diagonal (diag) branch.Due to disease of the lad and enlargement of the diag branch, double kissing crush technique was performed.After a non-bsc wire was used to cross the lesion, pre-dilatation was performed.A 2.50 x 28 synergy drug-eluting stent (des) was advanced through the diag; however, it had an issue with the guider and could not pass the stent into the lad.The stent was frozen in place and was wrapped around the lad balloon.They had to be deployed the stent in the diag.Upon removal of the delivery system, it was noted that the shaft fractured in the guider and the balloon separated from the catheter.A portion of the detached fragment remained in the guider where it was trapped and removed.The other portion of the balloon embolized to the descending aorta and was successfully removed using a bioptome despite numerous unsuccessful attempts.An 8f sheath was then placed and with guide liner support, a 1.25mm balloon catheter was advanced past the stent portion from the diag into the lad.Progression dilatation was performed with multiple balloon catheters with sizes 1.25, 2.0, 2.5 respectively.The lad was then stented with a 2.75 x 38 syngergy des, followed by a 3.0 x 20 des.The diag was then recrossed and simultaneous kissing balloon techniques were performed and the lad was post-dilated in multiple locations with a 3.25 non-compliant balloon at up to 18 atmospheres.Angiography revealed excellent result throughout the diag and the lad.Femoral angiography showed appropriate catheter placement in the common femoral artery and the procedure was completed after closure of the cath site with an 8f non-bsc device.No further patient complications were reported.
 
Event Description
It was reported that shaft break and embolization occurred.The patient presented with chest pain, rising troponins, and electrocardiogram changes which is consistent with ischemia.The target lesion was located in the left anterior descending artery (lad) and diagonal (diag) branch.Due to disease of the lad and enlargement of the diag branch, double kissing crush technique was performed.After a non-bsc wire was used to cross the lesion, pre-dilatation was performed.A 2.50 x 28 synergy drug-eluting stent (des) was advanced through the diag; however, it had an issue with the guider and could not pass the stent into the lad.The stent was frozen in place and was wrapped around the lad balloon.They had to be deployed the stent in the diag.Upon removal of the delivery system, it was noted that the shaft fractured in the guider and the balloon separated from the catheter.A portion of the detached fragment remained in the guider where it was trapped and removed.The other portion of the balloon embolized to the descending aorta and was successfully removed using a bioptome despite numerous unsuccessful attempts.An 8f sheath was then placed and with guide liner support, a 1.25mm balloon catheter was advanced past the stent portion from the diag into the lad.Progression dilatation was performed with multiple balloon catheters with sizes 1.25, 2.0, 2.5 respectively.The lad was then stented with a 2.75 x 38 syngergy des, followed by a 3.0 x 20 des.The diag was then recrossed and simultaneous kissing balloon techniques were performed and the lad was post-dilated in multiple locations with a 3.25 non-compliant balloon at up to 18 atmospheres.Angiography revealed excellent result throughout the diag and the lad.Femoral angiography showed appropriate catheter placement in the common femoral artery and the procedure was completed after closure of the cath site with an 8f non-bsc device.No further patient complications were reported.
 
Manufacturer Narrative
Device is a combination product.B3 date of event: used the first date of the month of the aware date as no event date was provided.A partial synergy ii us mr 2.50 x 38 mm device from distal tip to polymer extrusion was returned for analysis without the hypotube shaft including the hub/manifold.A visual examination of the stent found the stent was not returned for analysis since it had been deployed in the patient.The balloon body was reviewed; and no issues were noted.Blood like substance in the balloon and inflation lumen of the distal shaft was observed during analysis.There was indication that positive and negative pressure were applied to balloon.A visual and microscopic examination of the tip showed signs of damage on the distal edge of the tip.Tip damage most likely occurred when the tip was pushed against a restriction.The hypotube section of the device was not returned for analysis.A visual and tactile examination of the outer extrusion and mid-shaft section and visual examination of the inner extrusion found a break in the polymer extrusion section at 255 mm proximal to distal tip (the break was in the port bond, within the exchange port).This type of damage most likely occurred due to excessive force that could have been applied to the delivery system during withdrawal attempts.No other issues were identified during the product analysis.
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10164230
MDR Text Key195452451
Report Number2134265-2020-07208
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840275
UDI-Public08714729840275
Combination Product (y/n)N
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/21/2022
Device Model Number10605
Device Catalogue Number10605
Device Lot Number0025137620
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Date Manufacturer Received07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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