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 2019-03-20 for ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM manufactured by Av-temecula-ct.
[139336344]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of implant has been estimated. The stent remains in the patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[139336345]
It was reported that the patient presented emergently with a st segment elevation myocardial infarction (stemi). An absorb scaffold had been implanted 3-4 years prior; angiography revealed plaque rupture, some thrombus, and timi 2 flow in the proximal ramus artery. The lesion was direct stented with a xience xpedition device for treatment. There was no reported adverse patient sequela. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-02156 |
| MDR Report Key | 8436803 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-03-22 |
| Date Added to Maude | 2019-03-20 |
| 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 | CONNIE SPECK |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168 |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM |
| Generic Name | BIORESORBABLE DRUG ELUTING SCAFFOLD |
| Product Code | PNY |
| Date Received | 2019-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AV-TEMECULA-CT |
| Manufacturer Address | ABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2019-03-20 |