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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493926228220
Device Problems Balloon; Stent; Bent; Inflation Problem; Physical Resistance; Catheter
Event Date 06/06/2015
Event Type  Malfunction  
Event Description

It was reported that stent damage and partial balloon inflation occurred. Vascular access was obtained via the right femoral artery. The 90% stenosed , 25x2. 5mm, eccentric, de novo target lesion was located in the non-tortuous and mildly calcified mid left anterior descending artery (lad). A non-bsc guidewire was advanced to cross the lesion. Predilation was performed thrice with a 15x2mm emerge balloon catheter at 12 atmosphere for a duration of 10 seconds resulting to 50% residual stenosis. Subsequently, a 2. 25 x 28 synergy¿ drug eluting stent was selected for use and advanced to treat the lesion. As the stent was moved from the guidewire into the lad, the physician noted that the stent delivery balloon looked slightly inflated. Slight resistance was met while pushing the synergy¿ stent across the lesion but from angiography, the stent was advanced which seems like a smoother journey down for the synergy¿ stent. However, the stent suddenly shrunk away from the balloon markers. The physician was "shocked" and decided to remove the whole delivery system carefully to examine. Fortunately, the synergy¿ stent was removed intact and the stent was not dislodged. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. This product is only ous approved but it is similar to an approved us device.

 
Manufacturer Narrative

Device is a combination product. (b)(4).

 
Manufacturer Narrative

Device evaluated by mfr. : the stent delivery system was returned for analysis. A visual and microscopic examination found that the struts in the center of the stent were severely bunched together and distorted. The stent length was measured and was less than specification. It was also noted that the entire stent had moved approximately 1mm distally. This damage is consistent with the stent encountering a resistance or an obstruction. The balloon was visually and microscopically examined and no issues were noted with its profiles that could have potentially contributed to the complaint incident. All the balloon folds were present. The balloon was tightly wrapped, folded evenly and was not subjected to positive pressure. The balloon was found to have the stent impressions on the balloon material indicating that the stent was crimped per process in the correct location during manufacturing. A visual and microscopic examination found no issue with the profile of the devices markerbands. A visual and tactile examination found no issue with the shaft polymer extrusion profile. A visual and tactile examination found that the hypotube was kinked at various positions along its length. This type of damage is consistent with excessive force being applied to the delivery system. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical/ procedural factors. (b)(4).

 
Event Description

It was reported that stent damage and partial balloon inflation occurred. Vascular access was obtained via the right femoral artery. The 90% stenosed, 25x2. 5mm, eccentric, de novo target lesion was located in the non-tortuous and mildly calcified mid left anterior descending artery (lad). A non-bsc guidewire was advanced to cross the lesion. Predilation was performed thrice with a 15x2mm emerge balloon catheter at 12 atmosphere for a duration of 10 seconds resulting to 50% residual stenosis. Subsequently, a 2. 25 x 28 synergy¿ drug eluting stent was selected for use and advanced to treat the lesion. As the stent was moved from the guidewire into the lad, the physician noted that the stent delivery balloon looked slightly inflated. Slight resistance was met while pushing the synergy¿ stent across the lesion but from angiography, the stent was advanced which seems like a smoother journey down for the synergy¿ stent. However, the stent suddenly shrunk away from the balloon markers. The physician was "shocked" and decided to remove the whole delivery system carefully to examine. Fortunately, the synergy¿ stent was removed intact and the stent was not dislodged. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. This product is only ous approved but it is similar to an approved us device.

 
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Brand NameSYNERGY¿
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key4887223
Report Number2134265-2015-04092
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/24/2016
Device MODEL NumberH7493926228220
Device LOT Number0017343151
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/16/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/29/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/02/2015 Patient Sequence Number: 1
Treatment
RUNTHROUGH GUIDEWIRE
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