MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Model Number	H74938046740750
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent migration occurred.Vascular access was obtained utilizing bilateral access.The 60% stenosed target lesions were located in the non-tortuous and moderately calcified left and right iliac arteries.An 8.0 x 40 x 75 cm express® ld iliac / biliary stent was deployed in the right iliac artery and a 7.0 x 40 x 75 cm express® ld iliac / biliary stent was deployed in the left iliac artery.Angiography was performed, however, it was noted that there was no stent in the left iliac artery.Subsequent angiography revealed that the 7.0 x 40 x 75 cm stent had migrated into the lower aorta.A 35 guide wire was then placed through the migrated stent.A 20 mm non-bsc snare retrieval kit was used through the right iliac artery to fixate the guide wire and to prevent further migration.A 9 x 60 mm non-bsc balloon catheter was then inflated and the stent was pulled back into the left iliac artery.A 10 x 60 mm non-bsc balloon catheter was then inflated to further appose the stent.A 10 x 60 mm non-bsc stent was inserted into the 7.0 x 40 x 75 cm express® ld iliac / biliary stent to extend length and ensure full apposition and was followed by dilation with a 10x60 non-bsc balloon catheter.A 10 x 40 mm non-bsc stent was also inserted into the 8.0 x 40 x 75 cm express® ld iliac / biliary stent in the right iliac to further appose the stent and was followed by dilation with a 10 x 60 mm non-bsc balloon catheter and the procedure was completed.Angiography was performed and both iliac and stents looked good.No further patient complications were reported and the patient did well throughout the entire procedure.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7550047
• Report Number: 2134265-2018-04617
• Device Sequence Number: 16588146
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: 08714729392217
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2019
• Device Model Number: H74938046740750
• Device Catalogue Number: 38046-74075
• Device Lot Number: 0019467565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10X40MM CORDIS CONTROL ILIAC STENT; 10X60MM CORDIS CONTROL ILIAC STENT; 3 - 10X60 ABBOTT ARMADA BALLOONS; 9X60MM ABBOTT ARMADA BALLOON; BARD SNARE RETRIEVAL KIT 20 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR