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

Model Number H7493902416350

Device Problems Hole In Material (1293); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

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passed through the stent in question.This balloon was inflated several times to rated burst pressure (rbp) and was then withdrawn from the patient.The procedure was then completed with a fresh 3.75 x 16mm nc emerge mr balloon catheter advanced to the stented area and inflated several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.

• Brand Name: ION¿
• Type of Device: CORONARY 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 Key: 5571034
• MDR Text Key: 42443372
• Report Number: 2134265-2016-02677
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2016
• Device Model Number: H7493902416350
• Device Catalogue Number: 39024-1635
• Device Lot Number: 17461089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR