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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911316270
Device Problems Stent; Bent; Physical Resistance; Catheter
Event Date 05/08/2015
Event Type  Malfunction  
Event Description

It was reported that stent damage occurred. Vascular access was obtained via the left artery. The 93% stenosed, 12. 96x2. 75, eccentric, de novo target lesion contained <=45 degree bend and was located in the mildly tortuous and severely calcified left circumflex artery (lcx). After a 6fr vl3. 5 mach 1 guide catheter was advanced, a 0. 014 guidewire was advanced to cross the lesion. Following predilation with a 2. 75x20 non-bsc balloon catheter, a 2. 75x16mm promus element ¿ drug eluting stent was selected for use and advanced to treat the lesion. However, the device met significant resistance and was unable to reach the lesion. The device was removed and the physician noted that the tip of the stent was deformed. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis. A visual examination of the crimped stent found stent struts within the mid-section portion of the crimped stent were damaged and distorted out of their crimped position. The bumper tip of the device showed no signs of damage. The balloon cones profiles were reviewed and no issues were noted with the overall balloon profile. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. A visual and tactile examination found multiple kinks along the hypotube shaft. A visual and tactile examination found no issues with the shaft polymer extrusion profile. 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 occurred. Vascular access was obtained via the left artery. The 93% stenosed, 12. 96x2. 75, eccentric, de novo target lesion contained <=45 degree bend and was located in the mildly tortuous and severely calcified left circumflex artery (lcx). After a 6fr vl3. 5 mach 1 guide catheter was advanced, a 0. 014 guidewire was advanced to cross the lesion. Following predilation with a 2. 75x20 non-bsc balloon catheter, a 2. 75x16mm promus element ⠄rug eluting stent was selected for use and advanced to treat the lesion. However, the device met significant resistance and was unable to reach the lesion. The device was removed and the physician noted that the tip of the stent was deformed. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.

 
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Brand NamePROMUS ELEMENT ¿
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
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 Key4808608
Report Number2134265-2015-03303
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor,COMPANY REPRESENT
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2015
Device MODEL NumberH7493911316270
Device Catalogue Number39113-1627
Device LOT Number17098570
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/27/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/18/2014
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: 06/01/2015 Patient Sequence Number: 1
Treatment
MACH 1, 6FR VL3.5 GUIDE CATHETER
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