MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

B3: date of event: no date provided, used article date.Umut oguslu, gurkan danisan, burcak gumus (2022).Percutaneous transhepatic management of biliary strictures in patients with dysfunctioning plastic biliary endoprostheses.Turkish journal of medical sciences: vol.52: no.4, article 45.

Event Description

Reported via journal article that within this study, it was reported that instent occlusion occurred.The study aimed to present the experience of percutaneous transhepatic management of dysfunctioning plastic biliary endoprostheses (pbe) in patients with benign/malign biliary strictures.Twenty-nine patients (22 men, 7 women; mean age of 60.7 (range 33 - 88) years) diagnosed with dysfunctioning pbe were included.Percutaneous transhepatic biliary drainage and subsequent pbe dislodgment into the bowel were performed in all cases.Patient demographics, etiology of the biliary stricture, indication, technical success, complications, and clinical outcomes were gleaned from medical records.Seventeen patients had malignant strictures, while 12 patients had benign conditions.A total of 36 pbe (33 straight, 3 double-j) were treated.Six patients had more than one pbe.Successful dislodgement of the pbe was achieved in 28 (96.6%) of the cases.Monorail threading was performed in 8 cases while dislodgement by balloon friction was utilized in 21 patients.There was no statistical significance between benign and malignant biliary strictures regarding dislodgement duration (p equals 0.080).No major complication was encountered.Thirteen minor complications in 10 patients including abdominal pain (n equals 8) and mild hemobilia (n equals 5) were observed and treated conservatively.Uneventful passage of the pbe was reported by all patients with technical success.Mean follow-up was 22.8 (range 2 - 63) months.None of the patients showed bowel obstruction during pbe passage.Late complication was encountered in 7 patients.Instent occlusion was observed in 3/16 (18.8%) of the patients in the malignant group.Once of the three patients had a boston scientific stent implanted.Instent occlusion occurred at 7 months.While 4/12 (33.3%) of the patients showed signs of recurrent stenosis in the benign stricture group.Repeat drainage was performed in all.Percutaneous transhepatic methods aid as a reasonable alternative in the treatment of benign and malignant biliary strictures in patients with dysfunctioning pbe when endoscopic approaches fail or are not eligible.

Manufacturer Narrative

H6: evaluation conclusion codes (1): corrected from cmc known inherent risk of device to cause traced to intentional off-label, unapproved, or contraindicated use.B3: date of event: no date provided, used article date.Umut oguslu, gurkan danisan, burcak gumus (2022).Percutaneous transhepatic management of biliary strictures in patients with dysfunctioning plastic biliary endoprostheses.Turkish journal of medical sciences: vol.52: no.4, article 45.

Event Description

Reported via journal article that within this study, it was reported that instent occlusion occurred.The study aimed to present the experience of percutaneous transhepatic management of dysfunctioning plastic biliary endoprostheses (pbe) in patients with benign/malign biliary strictures.Twenty-nine patients (22 men, 7 women; mean age of 60.7 (range 33 - 88) years) diagnosed with dysfunctioning pbe were included.Percutaneous transhepatic biliary drainage and subsequent pbe dislodgment into the bowel were performed in all cases.Patient demographics, etiology of the biliary stricture, indication, technical success, complications, and clinical outcomes were gleaned from medical records.Seventeen patients had malignant strictures, while 12 patients had benign conditions.A total of 36 pbe (33 straight, 3 double-j) were treated.Six patients had more than one pbe.Successful dislodgement of the pbe was achieved in 28 (96.6%) of the cases.Monorail threading was performed in 8 cases while dislodgement by balloon friction was utilized in 21 patients.There was no statistical significance between benign and malignant biliary strictures regarding dislodgement duration (p equals 0.080).No major complication was encountered.Thirteen minor complications in 10 patients including abdominal pain (n equals 8) and mild hemobilia (n equals 5) were observed and treated conservatively.Uneventful passage of the pbe was reported by all patients with technical success.Mean follow-up was 22.8 (range 2 - 63) months.None of the patients showed bowel obstruction during pbe passage.Late complication was encountered in 7 patients.Instent occlusion was observed in 3/16 (18.8%) of the patients in the malignant group.Once of the three patients had a boston scientific stent implanted.Instent occlusion occurred at 7 months.While 4/12 (33.3%) of the patients showed signs of recurrent stenosis in the benign stricture group.Repeat drainage was performed in all.Percutaneous transhepatic methods aid as a reasonable alternative in the treatment of benign and malignant biliary strictures in patients with dysfunctioning pbe when endoscopic approaches fail or are not eligible.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17454826
• MDR Text Key: 320369041
• Report Number: 2124215-2023-40466
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention