MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, BALLOON TYPE

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 08/24/2015

Event Type  Death  

Manufacturer Narrative

Subject device is not available.

Event Description

Following percutaneous transluminal angioplasty (pta) using a balloon catheter (subject device), a stent was placed across the target lesion.Post procedure, the patient suffered a reperfusion hemorrhage.The patient died.The physician believed that the death was unrelated to the subject device.No further information was provided.

Event Description

Following percutaneous transluminal angioplasty (pta) using a balloon catheter (subject device), a stent was placed across the target lesion.Post procedure, the patient suffered a reperfusion hemorrhage.The patient died 9 days after the procedure.The physician believed that the death was unrelated to the subject device.No further information was provided.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, patient hemorrhage, blood loss with sequelae and death are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

Following percutaneous transluminal angioplasty (pta) using a balloon catheter (subject device), a stent was placed across the target lesion.Post procedure, the patient suffered a reperfusion hemorrhage.The patient died 9 days after the procedure.The physician believed that the death was unrelated to the subject device.No further information was provided.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5692460
• MDR Text Key: 46324524
• Report Number: 0002134265-2016-00008
• Device Sequence Number: 0
• Product Code: PAV
• Reporter Country Code: US
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/29/2016; 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2012
• 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
• Treatment: WINGSPAN STENT SYSTEM (STRYKER)
• Patient Outcome(s): Death; Other
• Patient Age: 52 YR