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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY ION¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493902416350
Device Problems Balloon; Stent; Hole In Material; Activation, Positioning or Separation Problem
Event Date 03/09/2016
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that stent inadequate apposition and balloon pinhole occurred. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery (mid rca). A 16mm x 3. 50mm ion drug-eluting stent was selected for used and advanced to treat the target lesion. Upon reaching the target lesion, the physician instructed the technologist assisting with the procedure to inflate the device. However, as the technologist increased the pressure on the inflation device, it was noticed that the pressure never went beyond 2 atmospheres even as more pressure was delivered. The inflation device was pulled negative and another attempt was made at inflation of the balloon and expansion of the stent in question. Again, the pressures never exceeds 2 atmospheres. The stent delivery catheter was then removed from the patient's body and a fresh 2. 00 x 15 emerge mr balloon catheter was inserted and passed through the stent in question. This balloon was inflated several times to rated burst pressure (rbp) and was then withdrawn from the patient. The procedure was then completed with a fresh 3. 75 x 16mm nc emerge mr balloon catheter advanced to the stented area and inflated several times to rbp along the entire length of the stent. Subsequent angiograms were then taken all displaying a excellent result with full expansion of the stented area. Outside the patient's body, when the ion was inflated, it was noted that there was a pinhole on the balloon catheter no patient complications were reported and the patient then left the catheterization laboratory pain free.

 
Manufacturer Narrative

Device evaluated by mfr. : the stent delivery system (sds) was returned for analysis. A visual and microscopic examination found that the stent had detached from the device and was not returned. The bumper tip was not damaged. There was a pinhole in the balloon material at the proximal end of the balloon. A visual and tactile examination found several hypotube kinks. A visual and tactile examination found no issue 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 inadequate apposition and balloon pinhole occurred. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery (mid rca). A 16mm x 3. 50mm ion drug-eluting stent was selected for used and advanced to treat the target lesion. Upon reaching the target lesion, the physician instructed the technologist assisting with the procedure to inflate the device. However, as the technologist increased the pressure on the inflation device, it was noticed that the pressure never went beyond 2 atmospheres even as more pressure was delivered. The inflation device was pulled negative and another attempt was made at inflation of the balloon and expansion of the stent in question. Again, the pressures never exceeds 2 atmospheres. The stent delivery catheter was then removed from the patient's body and a fresh 2. 00 x 15 emerge mr balloon catheter was inserted and passed through the stent in question. This balloon was inflated several times to rated burst pressure (rbp) and was then withdrawn from the patient. The procedure was then completed with a fresh 3. 75 x 16mm nc emerge mr balloon catheter advanced to the stented area and inflated several times to rbp along the entire length of the stent. Subsequent angiograms were then taken all displaying a excellent result with full expansion of the stented area. Outside the patient's body, when the ion⠗as inflated, it was noted that there was a pinhole on the balloon catheter no patient complications were reported and the patient then left the catheterization laboratory pain free.

 
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Brand NameION¿
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5571034
Report Number2134265-2016-02677
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/06/2016
Device MODEL NumberH7493902416350
Device Catalogue Number39024-1635
Device LOT Number17461089
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/22/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/28/2014
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: 04/12/2016 Patient Sequence Number: 1
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