MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2012-08-23 for DYNAMIC Y STENT M00570690 manufactured by Boston Scientific - Marlborough.
[3088878]
It was reported to boston scientific corporation that a dynamic y stent was used during a bronchoscopy procedure performed on (b)(6) 2012. According to the complainant, during the procedure, the stent rotated off the forceps and turned sideways. Since the physician could not remove the stent or position it properly, a ct surgeon then assisted in removing the stent from the patent. The patient's length of hospitalization was extended due to the event. Attempts to obtain additional information regarding the patient's current condition have been unsuccessful. **additional information received on (b)(6) 2012. ** the complainant confirmed that an ent (ears, nose and throat) physician successfully removed the stent using forceps through a rigid scope. Additionally, the physician reported that the patient has left the hospital and is in really good health.
Patient Sequence No: 1, Text Type: D, B5
[10430457]
The device was not returned; therefore, a technical analysis could not be performed. A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution. A search of the complaint database confirmed that no similar complaints exist for the specified batch. A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label. Based on the evaluation conducted and the details of the complaint, a definitive root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[15153985]
It was reported to boston scientific corporation that a dynamic y stent was used during a bronchoscopy procedure performed on (b)(6) 2012. According to the complainant, during the procedure, the stent rotated off the forceps and turned sideways. Since the physician could not remove the stent or position it properly, a ct surgeon then assisted in removing the stent from the patent. The patient's length of hospitalization was extended due to the event. Attempts to obtain additional information regarding the patient's current condition have been unsuccessful. **additional information received on (b)(6) 2012. ** the complainant confirmed that an ent (ears, nose and throat) physician successfully removed the stent using forceps through a rigid scope. Additionally, the physician reported that the patient has left the hospital and is in really good health.
Patient Sequence No: 1, Text Type: D, B5
[15271623]
.
Patient Sequence No: 1, Text Type: N, H10
[21761185]
It was reported to boston scientific corporation that a dynamic y stent was used during a bronchoscopy procedure performed on (b)(6), 2012. According to the complainant, during the procedure, the stent rotated off the forceps and turned sideways. Since the physician could not remove the stent or position it properly, a ct surgeon then assisted in removing the stent from the patent. The patient's length of hospitalization was extended due to the event. Attempts to obtain additional information regarding the patient's current condition have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[21883995]
(b)(4):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
[30064987]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30064988]
It was reported to boston scientific corporation that a dynamic y stent was used during a bronchoscopy procedure performed on (b)(6) 2012. According to the complainant, during the procedure, the stent rotated off the forceps and turned sideways. Since the physician could not remove the stent or position it properly, a ct surgeon then assisted in removing the stent from the patent. The patient's length of hospitalization was extended due to the event. Attempts to obtain additional information regarding the patient's current condition have been unsuccessful. Additional information received on october 1, 2012. The complainant confirmed that an ent (ears, nose and throat) physician successfully removed the stent using forceps through a rigid scope. Additionally, the physician reported that the patient has left the hospital and is in really good health. Additional information received on april 23, 2014. According to the complainant, during the procedure, the physician anesthetized the patient and the endotracheal tube was placed. The bronchoscope was inserted and both the right and left main bronchi were measured to be 2cm in length. A 15mm diameter dynamic y stent was chosen, and the right and left limbs of the stent were trimmed to 2cm in size and the tracheal component was trimmed 4 cm in size. The dynamic y stent was then loaded onto the insertion tool and advanced into place under fluoroscopic guidance. However, only the tracheal component of the stent was able to be visualized on the fluoroscopy and the insertion tool was withdrawn. It was noted that the stent was malpositioned in the right main bronchus and remained in the vertical position. The insertion tool was examined and it was noted that the distal end did not rotate. Attempts were made to retract the stent endoscopically with forceps but were unsuccessful. An ent physician removed the stent successfully using a rigid bronchoscope. The patient remained hemodynamically stable with good oxygenation above 92% throughout the entire procedure. The patient's airway appeared to be fairly edematous after the procedure. The patient was left intubated and was transported to the icu where she remained on a ventilator from (b)(6) 2012. The patient required replacement of her implanted teeth that were lost as a direct result of having to be intubated and on mechanical ventilatory assistance. On (b)(6) 2013 the patient passed away. To date, no relationship has been established between the patient's death and the stent placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2012-03795 |
| MDR Report Key | 2711904 |
| Report Source | 04,05,07 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-07-27 |
| Date of Event | 2012-07-27 |
| Date Mfgr Received | 2014-04-23 |
| Device Manufacturer Date | 2012-04-05 |
| Date Added to Maude | 2012-08-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. INGRID MATTE |
| 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 | NYT |
| Date Received | 2012-08-23 |
| Model Number | M00570690 |
| Lot Number | 0000012121 |
| Device Expiration Date | 2017-02-28 |
| Operator | PHYSICIAN |
| 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. Required No Informationntervention | 2012-08-23 |