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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE
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BOSTON SCIENTIFIC - GALWAY WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE Back to Search Results
Model Number M00565110
Device Problem Partial Blockage (1065)
Patient Problems Death (1802); Perforation (2001)
Event Type  Death  
Event Description
It was reported to boston scientific corporation that a wallflex¿ enteral colonic stent was implanted during a colonic stent placement procedure performed on (b)(6) 2014.The wallflex stent was deployed in the colon sigmoideum without any issues.The wallflex stent placement procedure was performed as a palliative case due to primary colonic cancer.The patient has not undergone any cancer treatments, such as radiotherapy or chemotherapy.According to the complainant, the stent had been implanted for approximately 6 months and the patient had been doing well.However, on or about (b)(6) 2015, the physician confirmed that the distal side of the wallflex stent was occluded from a re-stricture due to ingrowth.At that time, a niti-s colonic stent (size: unknown) was deployed inside the distal side of the wallflex enteral colonic stent.The physician did not mention if there were any difficulties placing the niti-s colonic stent that may have contributed to the perforation.However, tortuosity was confirmed.Perforation was noted a month after the placement of the niti-s colonic stent and the patient expired.Before the patient expired, she had metastatic liver cancer.It is currently unknown whether or not an autopsy was conducted.The physician who performed the placement procedure of the niti-s colonic stent stated that he does not know the site where the perforation occurred.The physician noted primary cause of the patient¿s death as stent perforation.Per the physician¿s assessment, the relationship between the patient¿s death and the wallflex stent is undetermined.It was undetermined if the wallflex stent caused or contributed to the perforation.Per the physician¿s assessment, the relationship between the patient¿s death and the niti-s colonic stent is undetermined.The physician did not verify which stent perforated the colon.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4) stent blocked/occluded.The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a wallflex¿ enteral colonic stent was implanted during a colonic stent placement procedure performed on (b)(6) 2014.The wallflex stent was deployed in the colon sigmoideum without any issues.The wallflex stent placement procedure was performed as a palliative case due to primary colonic cancer.The patient has not undergone any cancer treatments, such as radiotherapy or chemotherapy.According to the complainant, the stent had been implanted for approximately 6 months and the patient had been doing well.However, on or about (b)(6) 2015, the physician confirmed that the distal side of the wallflex stent was occluded from a re-stricture due to ingrowth.At that time, a niti-s colonic stent (size: unknown) was deployed inside the distal side of the wallflex enteral colonic stent.The physician did not mention if there were any difficulties placing the niti-s colonic stent that may have contributed to the perforation.However, tortuosity was confirmed.Perforation was noted a month after the placement of the niti-s colonic stent and the patient expired.Before the patient expired, she had metastatic liver cancer.It is currently unknown whether or not an autopsy was conducted.The physician who performed the placement procedure of the niti-s colonic stent stated that he does not know the site where the perforation occurred.The physician noted primary cause of the patient¿s death as stent perforation.Per the physician¿s assessment, the relationship between the patient¿s death and the wallflex stent is undetermined.It was undetermined if the wallflex stent caused or contributed to the perforation.Per the physician¿s assessment, the relationship between the patient¿s death and the niti-s colonic stent is undetermined.The physician did not verify which stent perforated the colon.**additional information received on june 18, 2015** the patient developed peritonitis after the colonic perforation was noted.The date that the peritonitis was discovered was unknown.In the physician's assessment, the peritonitis was caused by the perforation.The physician believed that there was a relationship between the perforation and the patient's death.The peritonitis did not resolve prior to the patient's death.
 
Manufacturer Narrative
Additional information received on (b)(6), 2015,.
 
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Brand Name
WALLFLEX? COLONIC
Type of Device
STENT, COLONIC, METALIC, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4740901
MDR Text Key15896554
Report Number3005099803-2015-01148
Device Sequence Number1
Product Code MQR
Combination Product (y/n)N
PMA/PMN Number
K061877
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/08/2015
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
Device Operator Physician
Device Model NumberM00565110
Device Catalogue Number6511
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/18/2015
Initial Date FDA Received04/30/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age81 YR
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