MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-12 for DYNAMIC Y STENT UNK110 manufactured by Boston Scientific - Marlborough.
[16775161]
It was reported to boston scientific corporation that a dynamic y stent was implanted in the trachea during an endoscopic stent deployment procedure performed in (b)(6) 2013. According to the complainant, the stent was implanted to treat a tracheomalacia. At some time post-procedure (exact date unknown), the patient started experiencing cough and shortness of breath. On (b)(6) 2014, the patient had a bronchoscopy to clear out secretions. The physician noted that the posterior membrane of the stent had separated with a clear saw tooth pattern. It was also noted that the posterior membrane had broken. According to the physician, the membrane was collapsing into the patient? S airway which caused the patient to accumulate secretions and develop crusts. The patient's condition at the conclusion of the procedure was reported to be fine. Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event. Should additional relevant details become available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[17089772]
The complainant was unable to report the upn and lot number; therefore the manufacture date and expiration date are unknown. (b)(4) stent broken. The complainant indicated that the device remains implanted and 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
[28506549]
Patient Sequence No: 1, Text Type: N, H10
[28506550]
It was reported to boston scientific corporation that a dynamic y stent was implanted in the trachea during an endoscopic stent deployment procedure performed in (b)(6) 2013. According to the complainant, the stent was implanted to treat a tracheomalacia. At some time post-procedure (exact date unknown), the patient started experiencing cough and shortness of breath. On (b)(6), 2014, the patient had a bronchoscopy to clear out secretions. The physician noted that the posterior membrane of the stent had separated with a clear saw tooth pattern. It was also noted that the posterior membrane had broken. According to the physician, the membrane was collapsing into the patient's airway which caused the patient to accumulate secretions and develop crusts. The patient's condition at the conclusion of the procedure was reported to be fine. Updated information received on 13mar2014. The patient was readmitted (exact date unknown) for worsening shortness of breath. The patient developed pseudomonas pneumonia and bronchoscopy was done to clear out the patient's secretions. According to the physician, the patient will be sent to another health care facility for further treatment and possible replacement of the stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2014-01416 |
| MDR Report Key | 3675569 |
| Report Source | 05,07 |
| Date Received | 2014-03-12 |
| Date of Report | 2014-02-20 |
| Date of Event | 2014-02-10 |
| Date Mfgr Received | 2014-03-13 |
| Date Added to Maude | 2014-03-12 |
| 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 | 2014-03-12 |
| Model Number | UNK110 |
| 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 | 2014-03-12 |