MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-12 for ABSORB UNK ABSORB manufactured by Abbott Vascular.
[180334689]
Date of event has been estimated. Implant date has been estimated. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided. The investigation was unable to determine a conclusive cause for the reported complaints. A conclusive cause for the reported patient effects of intimal dissection, hematoma, thrombosis, prolapse and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device. The additional malfunctions referenced are being filed under a separate medwatch report #.
Patient Sequence No: 1, Text Type: N, H10
[180334690]
It was reported through a research article identifying absorb bioresorbable vascular scaffold (bvs) that may be related to the following: under-expansion, malposition, edge dissection, thrombus and or plaque protrusion, scaffold fracture, and intramural hematoma. Specific patient information is documented as unknown. Details are listed in the attached article, titled absorb bioresorbable vascular scaffold outcomes following implantation with routine intravascular imaging guidance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01405 |
| MDR Report Key | 9700369 |
| Report Source | LITERATURE |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2014-11-01 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-12 |
| 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 | 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 | 2020-02-12 |
| Catalog Number | UNK ABSORB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2020-02-12 |