MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-28 for ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT UNK518 manufactured by Boston Scientific - Marlborough.
[87722685]
The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). Udd, marianne, et al. "problems related to levodopa-carbidopa intestinal gel treatment in advanced parkinson's disease. " brain and behavior (2017). Doi: 10. 1002/brb3. 737. 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.
Patient Sequence No: 1, Text Type: N, H10
[87722686]
Boston scientific corporation became aware of multiple events through the article "problems related to levodopa-carbidopa intestinal gel treatment in advanced parkinson? S disease" written by marianne udd, et al. According to the literature, the aim of the study was to determine the clinical outcome of lcig in patients with advanced pd in the years 2006-2014 at helsinki university hospital. The study included 60 patients total, of these patients, 9 were implanted with a boston scientific endovive initial placement peg kit. The other patients were implanted with non-bsc peg tubes. All of the 60 patients had peg-j tube procedures which were inserted under endoscopic and fluoroscopic control by gastroenterologic surgeons in the endoscopic unit using the pull-through method. Antibiotic prophylaxis (1. 5 g cefuroxime, zinacef? , glaxosmithkline, (b)(4)) and local anesthesia with lidocaine (10 mg/ml lidocain? , orio, (b)(4)) were administered, and conscious sedation was provided by an anesthesiologist. After placement of the peg tube, the inner j tube was moved near the ligamentum of treitz with rat-tooth forceps. If this failed, a guidewire (jagwire, boston scientific, (b)(4)) and a triple lumen balloon were passed to the duodenum, the balloon was retrieved and the j tube was inserted over the guidewire. The position of the inner tube was controlled under fluoroscopy. The peg-j was connected to a portable infusion pump (cadd legacy 1400 duodopa pump, smits medical (b)(4) usa). Of the 60 total patients, 9 were implanted with the boston scientific endovive initial placement peg kit. Additional information below was received from the corresponding author regarding the specific failures for the boston scientific enteral feeding tubes. Out of the 9 patients 7 of them had some complications on levodopa-carbidopa intestinal gel (lcig) treatment. Tube complications were, buried bumper syndrome of the peg tube (bolster stuck and bolster/button migration) (n=1), skin problems and leaking stoma (n=1), skin infection and abscess (n=3), granulation of tissue (n=1), peg tube blocked/occluded (n=5), and split/torn peg tubes (n=2). Out of the 9 patients, 8 patients had to come back multiple times for endoscopic procedures. The numbers indicate the number of incidences that occurred. The complications were: peg tube occlusion (n=9), split/torn peg tubes (n=10), and stoma leak (n=2). Cumulatively, peg tube was placed or exchanged (n=4), both the peg and jejunal tubes were exchanged (n=20), the tubes were tested and checked with fluoroscopy or gastroscopy, exchanging the caps (n=5), and the boston scientific endovive through the peg jejunal feeding tube was removed (n=2).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02955 |
| MDR Report Key | 6902274 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-28 |
| Date of Report | 2017-08-31 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-09-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2017-09-28 |
| Model Number | UNK518 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-28 |