MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-08-17 for DYNAMIC Y STENT M00570680 manufactured by Boston Scientific - Marlborough.
[82959830]
The lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined. The patient was initially seen at (b)(6) hospital. The patient was referred out to a specialist, dr. (b)(6), where the dynamic y stent was implanted. After the patient went into arrest, the patient was taken to (b)(6) hospital, and was then transferred to (b)(6)hospital, where the patient was under the care of dr. (b)(6). (b)(4). The device has not been received for analysis; 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
[82959831]
It was reported to boston scientific corporation that a dynamic y stent was successfully implanted to treat excessive dynamic airway collapse (edac) during a bronchoscopy procedure on (b)(6) 2017. The patient was kept for observation for 3 days post procedure and was reported to be fine at that time. On (b)(6) 2017, the patient was found on the floor of their home in arrest. The patient was taken to the hospital, treated, and then transferred to another hospital. The patient then died while at this hospital. Reportedly, the physician is not sure if the dynamic y stent is related to the patient's arrest and death. The patient's cause of death was not reported. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[96156837]
Additional information received on september 01, 2017. The physician mentioned in the additional information is dr. (b)(6) of (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[96156838]
It was reported to boston scientific corporation that a dynamic y stent was successfully implanted to treat excessive dynamic airway collapse (edac) during a bronchoscopy procedure on (b)(6) 2017. The patient was kept for observation for 3 days post procedure and was reported to be fine at that time. On (b)(6) 2017, the patient was found on the floor of their home in arrest. The patient was taken to the hospital, treated, and then transferred to another hospital. The patient then died while at this hospital. Reportedly, the physician is not sure if the dynamic y stent is related to the patient's arrest and death. The patient's cause of death was not reported. Additional information received on september 01, 2017: a physician familiar with the case speculated that, during the placement procedure, the dynamic y stent may have been modified incorrectly, allowing it to move within the trachea. However, the physician did not see any evidence to indicate that the stent had moved out of position or that there was any issue with the stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02463 |
| MDR Report Key | 6802121 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-17 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-06-09 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-08-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUESCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC Y STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | JCT |
| Date Received | 2017-08-17 |
| Model Number | M00570680 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Brand Name | DYNAMIC Y STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2017-08-17 |
| Model Number | M00570680 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Death | 2017-08-17 |