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 2020-01-22 for ABSORB 1234250-28 manufactured by Abbott Vascular.
[175918877]
The stent remains in patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Date of event has been estimated, date of implant has been estimated.
Patient Sequence No: 1, Text Type: N, H10
[175918878]
It was reported that on (b)(6) 2015 the procedure was performed to treat the left anterior descending artery and an unspecified size absorb scaffold was implanted. Scaffold-thrombosis was observed, and an acute posterior infarction occurred one week after therapy was stopped. On (b)(6) 2016, the thrombosis was recanalized and dilatated with an unspecified balloon. Medication was provided as treatment. There was no adverse patient sequela reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-00827 |
| MDR Report Key | 9616919 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-22 |
| Date of Report | 2020-02-27 |
| Date of Event | 2016-12-05 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-01-22 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABSORB |
| Generic Name | BIORESORBABLE SCAFFOLD |
| Product Code | PNY |
| Date Received | 2020-01-22 |
| Catalog Number | 1234250-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-22 |