MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-12-20 for ABSORB UNK ABSORB manufactured by Abbott Vascular.
[176096591]
Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated. Exemption number e2019001. The scaffolds remain in patients. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The absorb device is currently not commercially available in the u. S; however, it is similar to a device sold in the u. S. Article, titled "magmaris very late in-scaffold restenosis: has the 'black boxes' nightmare come back? ".
Patient Sequence No: 1, Text Type: N, H10
[176096592]
It was reported through a research article identifying absorb scaffolds that may be related to the following: very late restenosis that seems to be attributed to pure intrascaffold tissue growth without extrinsic encroachment of the scaffold. Details are listed in the attached article, titled "magmaris very late in-scaffold restenosis: has the 'black boxes' nightmare come back? ".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-14843 |
| MDR Report Key | 9504131 |
| Report Source | LITERATURE |
| Date Received | 2019-12-20 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2019-12-20 |
| 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 | 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 | 2019-12-20 |
| Catalog Number | UNK ABSORB |
| 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. Other | 2019-12-20 |